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 .
This action is in response to papers filed November 26, 2025. The amendments have been thoroughly reviewed and entered. Any previous objection/ rejection not repeated herein has been withdrawn.
Applicant's arguments have been thoroughly reviewed but are deemed moot in view of the amendments, withdrawn rejections and new grounds for rejection. New and/or modified grounds for rejection, necessitated by the amendments, are discussed.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1 and 33-37, drawn to a kit for preparing a cell suspension, classified in B01L3/502707.
II. Claims 38-51, drawn to a method of preparing a cell suspension, classified in Y10T 436/12.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the device as claimed can be practiced using another and materially different process that does not require the steps of at least identifying a first match between a first label disposed proximate to a first reservoir of the device and a first visual indicator included in the first housing portion of the housing.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(b) the prior art applicable to one invention would not likely be applicable to another invention; and
(c) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these 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.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Sophia Zahn on January 15, 2026 and a provisional election was made without traverse to prosecute the invention of group I, claims 1 and 33-37 . Affirmation of this election must be made by applicant in replying to this Office action. Claims 38-51 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The examiner has considered the information disclosure statements (IDS) submitted on August 18, 2025. However, due to the large number of documents (over 300 references cited), the examiner was unable to thoroughly review each document in the available search and examination time.
There is no duty for an examiner to consider such references to a greater extent than those ordinarily looked at during a regular search by an examiner. Accordingly, the examiner has considered these references in the same manner as references encountered during a normal search and examination. If applicant believes there are specific documents, or parts thereof, that are highly relevant or material to the patentability of the instant claims, the examiner suggests that applicant specifically identify such documents and note the relevant portions thereof. See MPEP §2004, item 13. Please refer to the signed copy of the PTO-1449 form attached herewith.
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 33-37 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 1, line 6, now recites “a preparation tray, wherein the preparation tray comprises a bottom surface surrounded by side walls”. However, it is not clear from the claim how tray is structurally/functionally related to the other elements of the device (i.e., the first reservoir, the second reservoir, heater, and the housing). As currently recited, the preparation tray not attached to the any other elements in the “device” (such as the first reservoir, second reservoir, and heater). In current US patent practice a “device claim” defines an invention by specifying the physical structure, attributes, and distinctive features of a particular device as a standalone entity. It concentrates on the individual components or physical elements that make up the invention, illustrating its design and configuration in detail (see MPEP 2173). Specifically in this case, all of the claimed elements that make up the device should be either structurally or functionally recited and related such that they at least perform the intended use, which is defined in claim 1, line 8 as a “device as configured to prepare a cell suspension comprising cells from a disaggregated skin sample”. However, if the tray is interpreted as part of the kit, and not the device then it should be recited as “the kit comprising a device, a tray, and a housing”. In which case, the structural or functional relationship between the device, tray and housing should be described in the claim. Since it is unclear what purpose the tray has with device or the kit the scope of the claim is unclear. The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent.
Claim 1 recites a housing configured to receive the device. However, the housing is defined by a first housing portion configured to a store a first set of components including a first visual indicator and an enzyme and a second housing portion configured to store a second set of components, including a buffer and a second visual indicator. However, the first housing and second housing portions do not receive the device, just other components (writing and containers). This is confusion and indefinite.
In addition, claim 1 now recites “a first housing portion configured to store a first set of components…wherein the first set of components comprise an enzyme”. The housing portion “configured to store a first set of components” does not positively recite the first set of components as part of the kit. Also claim 1 further limits the first set components as comprising an enzyme, which is also not positive recitation. Therefore it is unclear if applicant intends for the set of component and the enzyme therein to be positively recited and thereby limiting the scope of the claim. This same reasoning is applicable to the second housing portion and the second set of components comprising a buffer.
As discussed above claim 1 recites “a first set of components…wherein the first set of components comprises an enzyme”. It is not clear how a first set of components (a structural element) can be considered an enzyme. Also a set of components necessarily requires more than one component. So it is unclear how a set of components matches in number with an enzyme. Also, by the limitation “components” does this refer to containers that contain the enzyme? Note: “an enzyme” can also be interpreted as a single molecule or a plurality of molecules, which also results in confusion as to scope of the claim. Do all of the “components” contain the same enzyme? For clarity the examiner recommends applicant positively reciting what specific structure(s) are included in a set of components and what applicant means by enzyme. This same reasoning is applicable to the second housing portion and the buffer.
In addition, claim 1 now recites a first reservoir configured to receive an enzyme mixture and a second reservoir configured to receive a buffer. How does the enzyme mixture in the first reservoir which a part of the device relate to the first housing portion having a set of components (containers?) comprising an enzyme, which is part of housing? Same reasoning is applicable to the second reservoir, the second housing portion and the buffer.
New claim 33 recites “the first visual indicator is associated with a first label of the device” and the second visual indicator is associated with a second label of the device”. First, it not clear from the claim what applicant means by phrase “associated with”. Does this mean they are aligned, matching, same color? Second, the first and second label of the device is not positively recited as part of the device. Thus, attempts to define the visual indicators on the housing portions with the elements not required (first label and second labels) in the device are confusing and indefinite.
New claim 34 recites the preparation tray is sloped. Claim 1 recites the preparation tray includes a bottom surface surrounded by sidewalls. Which part of the tray is considered “sloped” and relative to what? Is this a method of using such as tilting the tray? This is confusing and indefinite.
New claim 35 recites the bottom surface (of the tray) comprises a primary surface, a lower surface, and a transition surface, wherein the transition surface tapers and slopes downward from the primary surface to the lower surface. It is not clear what applicant means by “tapered” and “sloped” downwards since no surface of the tray has been defined as an upper surface. Also this is confusing and indefinite since there is no structural distinction from the “primary surface” to the “lower surface”.
New claim 36, recites the preparation tray is recessed. What is the tray recess relative to? This is confusing and indefinite.
New claim 37 recites the first reservoir is configured to receive a skin sample and disaggregate the skin sample. It is unclear how this skin sample and disaggregated skin sample in claim 37 relate to previously recited “cells from a disaggregated skin sample” now recited claim 1. Are they referring to the same skin sample and cells?
Prior art
Note: MPEP 2173.06(II) states, “where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 102 and/or 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.” However in interest of compact prosecution, in this case, the examiner has attempted to map the limitations of the claims relative to the closest prior art, as set forth in item #7 below.
Claim Interpretation
In the patentability analysis of kit claims, aspects or limitations the examiner interprets as functional are generally italicized whereas aspects interpreted as structural components are normally bolded. The bold font and italics are shown when the structure and function are initially introduced though not necessarily repeated, particularly in dependent claims. The examiner applies this formatting for both the examiner and applicant’s convenience. However, absent the referenced typestyles, the patentability analysis will still be clear regarding which limitations the examiner interprets as structural versus functional.
The claims are apparatus/device/kit claims requiring only the recited structural components, although structured with physical features that can perform the stated functions or the intended uses. Functional limitations state either an intended use or operation, a manner of operating a device, apparatus or system, or what the apparatus/system does. Apparatus claims cover what a device is, not what a device does. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Also, a claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Of course, the patentability analysis of these apparatus/kit claims including the functional features are not ignored and applicant can and should employ such language where appropriate and helpful. However, if a prior art structure is capable of performing the intended use, or if such apparatus can operate in the manner described, then it meets the claim limitation (MPEP §§ 2114, 2173.05(g)).
In summary, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997).
The below patentability analysis provides one or more interpretations and claim mappings of the claimed structures and/or limitations although other interpretations may be possible. In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification. However, specific limitations from the specification are not read into the claims. See MPEP §§2111, 2173.01 I.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 33-37, as best understood, are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by RECELL Autologous Cell Harvesting device (dated 2018) and cited in the IDS filed August 18, 2025, hereinafter “RECELL” or “MedWatch Today: RECELL device helping burn patients heal faster and more efficiently”, also recited in the IDS filed August 18, 2025.
As to claim 1, RECELL teaches a kit for preparing a cell suspension, the kit comprising:
a device, the device comprising:
a first reservoir (Well A) configured to receive and enzyme mixture;
a heater configured to heat the enzyme mixture in the first reservoir (see on page 1, “press run button to heat Enzyme”);
a second reservoir (Well B) configured to receive a buffer; and
a preparation tray (see modified Figure below found on last page), wherein the preparation tray comprises a bottom surface surrounded by sidewalls;
wherein the device is configured to prepare a cell suspension comprising cells from a disaggregated skin sample and
a housing configured to receive the device, the housing including:
a first housing portion (reads on box labeled A Enzyme Set) configured to store a first set of components, the first housing portion including a first visual indicator (i.e., label A and/or Enzyme set) wherein the first set of components comprise an enzyme; and
a second housing portion (see box labeled B Buffer Solution Set) configured to store a second set of components, the second housing portion including a second visual indicator (i.e., label B and/or Buffer solution Set), wherein the second set of components comprise a buffer.
Regarding claim 33, RECELL teaches the first visual indicator (i.e., label A on the first housing portion (box)) is “associated with” (interpreted as the same indicator such as A) a first label of the device (i.e., label A on well in device), and the second visual indicator (i.e., label B on the second housing portion (box)) is associated (interpreted as the same indicator such as B) with a second label of the device (i.e. label B on well in device).
Regarding claim 34, RECELL shows at least sidewalls of the preparation tray are sloped (see Fig below).
Regarding claim 35, RECELL teaches the bottom surface comprises a primary surface, a lower surface, and a transition surface, wherein the transition surface tapers and slopes downward from the primary surface to the lower surface.
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With respect to claim 36, RECELL teaches the preparation tray is recessed (interpreted as having sidewalls and flat bottom).
Claim 37 is considered an intended use claim, which does not patentably distinguish it from the prior art. Nevertheless, RECELL teaches the first reservoir is configured to receive a skin sample and disaggregate the skin sample (see Stage A-Enzymatic Processing step one place the skin samples in Well A for 15-20 minutes).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 33-37 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
i. Bowman et al., (US 4,736,850) which teach cell harvesting kit and a method for harvesting cells from a vein of a patient are provided. The cell harvesting kit has a packaging container containing three trays, a support holding the components needed for cell harvesting, and three vials containing enzyme solutions and salt solution, respectively. The three trays include an outer tray having a lid engaged with the outer tray to preserve sterility, a component tray within the outer tray, the component tray having a sealed lid and having a shelf about its perimeter for supporting a support member having depressions therein for holding the components needed in cell harvesting, and a third tray contained within the component tray, the third tray comprising a process tray with a trough in which an excised vein may be placed for harvesting; and
ii. Vacher et al., (US 2018/0298334) which teach a device and a process for dissociating cells derived from a freshly taken tissue sample, comprising the following steps: [0016] (i) initiating the crystallization in a warmer consisting of a hermetic plastic pouch containing a sodium acetate-saturated aqueous solution; optionally, placing said warmer in a cavity provided for this purpose in a support, preferably an insulating support; [0017] (ii) placing on said warmer a container containing a solution of trypsin having a concentration between 0.2% and 1%; [0018] (iii) placing the tissue sample in said solution and leaving to incubate for at least 10 minutes, preferably 15 to 20 minutes; [0019] (iv) rinsing the tissue sample; and
iii. Wood et al., (US 2002/0106353) which teach at FIG. 2 provides a partially exploded perspective view of the apparatus 10 wherein the second member 30 is removed from the first member 18 and inverted. Inversion of the second member 30 reveals the sidewalls 32 of the second member 30, which form the fluid containment barrier of the reservoir and a reservoir area 34 in which tissue manipulations may be performed. [0121] Removal of the second member 30 from the first member 18 also reveals a storage compartment 36 in the first member 18 in which solutions and tools may be stored when the apparatus 10 is not in use. Within the storage compartment 36 there is located a seat 38 upon which the second member 30 may reside. The seat 38 is preferably located around the periphery of the storage compartment 36 at a depth beneath the surface of the first member 18 that is equivalent to the height of the sidewalls 32 of the second member.[0122] FIG. 3a provides a perspective view of the first member 18 showing the storage compartment 36, the heater activating switch 24, the aperture 20, the fluid containment well 26 and filter recess 28 formed within the first member. FIG. 3b provides a rear view of the first member 18 showing the filter recess 28, the fluid containment well 26, the heater activating switch 24, the aperture collar 21 and the rear wall of the storage compartment 36. As seen in this figure the filter recess has a conical base thereby providing a means for easy access to the cell suspension that is filtered into it. Located adjacent to the fluid containment well and on the opposite side of the filter containment well there is also provided a battery positioning member 40 which protrudes towards the base 16 of the apparatus (not shown) and provides a means for holding the batteries in place, which are required for activating the heating means.
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 P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached on 9:30am-7:30 pm EST.
Examiner interviews are available via telephone 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.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798