Final Rejection
Reissue
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Status of Claims
Patent claims 1-20 as amended and new claims 21-27 and 29-38 are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “disintegrating member” in claim 21 and its dependents.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 1-8, 11, 13, and 38 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 3,941,317 to Kanor.
With respect to claims 1 and 38, Kanor teaches a device for preparing cells, the device including a tissue processing chamber 33 configured to receive a tissue and a fluid (col.4, lines 5-16). The chamber of Kanor is configured to receive a chemical reagent because it has a structure capable of doing so. Notably the instant claim does not recite any structure that would distinguish a chamber “configured to receive a tissue and a chemical reagent” from that of Kanor because the chemical reagent is not positively recited or required by the apparatus claim.
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The device of Kanor further includes a reciprocating-rotating pestle 35,29 (col.4, lines 19-24 and 66-68) in the tissue processing chamber, wherein the reciprocating-rotating pestle is actuatable to exert a grinding force directly on the tissue, wherein the force mechanically dissociates the tissue (col.4, lines 18-24). Note that Kanor teaches that the layer of mesh 29 is placed over the surface of the pestle “and secured in place” such that it is tightly fastened to the head of the pestle. See col.3, lines 21-26; Fig. 1. Thus, the mesh is integral with the pestle and does not function independently therefrom such that the pestle as a whole (i.e. the pestle head and fastened mesh) exerts a grinding force directly on the tissue. Kanor further discloses a cell collection chamber (conical receptacle below filter screen 37) configured to collect a cell suspension 32 (Fig.2). The collection chamber is configured to and capable of receiving chemically and mechanically dissociated tissue from the tissue processing chamber. The claim does not recite any structure that would distinguish a chamber “configured to collect a cell suspension comprising the chemically and mechanically dissociated tissue” from that of Kanor.
As to claims 2 and 3, Kanor teaches a screen disintegrator 36 separating the tissue processing chamber from the cell collection chamber.
With respect to claim 4, a filter 37 is arranged in the device of Kanor between the disintegrator 36 and the cell collection chamber.
As to claims 5 and 6, the device of Kanor includes a cap 39 removably placed on the tissue processing chamber and a pestle 35 connected via annular contact portion 39a. See col.5, lines 1-16 and 26-34).
With respect to claim 7, Kanor teaches the pestle exerts a compression and a rotation force (col.4, lines 19-24).
As to claims 8, 11, and 13, a hypodermic syringe 13 in fluid communication with the cell collection chamber receives the cell suspension. See col.4, lines 58-63. A hypodermic syringe is capable of dispensing the suspension and is removable from communication with the cell collection chamber (col.4, lines 16-17).
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.
Claim(s) 9, 10, 14, 15, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanor in view of Hedrick.
With respect to claim 9, Kanor is silent to a pump configured to drive the cell
suspension from the cell collection chamber to the syringe 13. However in a tissue disaggregation device, Hedrick discloses the known use of a pump 34 for draining the disaggregated tissue from cell collection chamber 30. Hedrick notes that the chamber can be drained “using gravity, by applying positive or negative pressure, by use of pumps 34 or by use of vents 32. See para [0102]. Kanor discloses the use of negative pressure (e.g. the suction produced by the syringe piston) for removal of the cell suspension from the chamber. As Hedrick teaches that a pump is a suitable replacement for negative pressure, it would have been an obvious modification to Kanor because the substitution of one known element for another yields predictable results to one of ordinary skill in the art. See MPEP 2143 I. B.
As to claim 10, Kanor does not teach a filter between the cell collection chamber and the applicator. Hedrick teaches that it is useful to filter the cell suspension after disaggregation in order to separate and concentrate particular subpopulations of cells, as well as to remove unwanted components. See paras [0111-01113]. The filter assembly 36 is located upstream of the output 50. In order to produce a suspension having the desired characteristics prior to use as taught by Hedrick, it would have been obvious to provide a filter between the cell collection chamber and the applicator of Kanor.
With respect to claim 14, Kanor is silent to a support in fluid communication with the cell collection chamber. However, Hedrick discloses that it was known in the art to apply the cells via “ports and conduits” to “a preformed matrix or scaffold” (paras [0139, 0153). One would have found it obvious to fluidly connect the cell collection chamber of Kanor to a matrix or scaffold in the manner of Hedrick, when using the produced cells for implant or culture. Note that Kanor discloses use of the produced cells in “medical research and treatment” (col.1, lines 6-14).
As to claim 15, Kanor does not teach a container of chemical reagent in fluid communication with the tissue processing chamber 33. However, in a similar apparatus Hedrick teaches a container of chemical reagent 24 in fluid communication with a tissue processing chamber 20. See paras [0090-0091, 0096]; Figs.1-3. As chemical disaggregation agents assist in separating cells from other tissue components, the addition of a reagent container in fluid communication with the tissue processing chamber of Kanor would have been obvious to one of ordinary skill in the art.
With respect to claim 18, Kanor discloses a physiologic fluid medium such as isotonic saline solution may be added to the interior of the tissue processing chamber but does not describe a container of buffered solution in communication with the chamber. Hedrick teaches a washing solution 23, that may be buffered or unbuffered saline, in fluid connection with the tissue processing chamber. See paras [0090, 0093]; Figs.1-3. One of ordinary skill in the art would have found it obvious to use buffered saline in the device of Kanor, as Hedrick discloses that the “types of tissue being processed will dictate the types or combinations of washing solutions used.” See para [0093]. Further, it would have been obvious to provide a container of the washing solution in fluid communication with the processing chamber of Kanor, so as to have a readily available means of adding washing solution as needed.
As to claims 19 and 20, Kanor is silent as to a container of an exogenous agent in fluid communication with the processing chamber. Hedrick discloses additional containers may be provided with additives to enhance the results of the aggregation process. These additives include exogenous agents, such as growth factors. See paras [0106, 0142, 0146]. In order to enhance the tissue aggregation results in the device of Kanor, it would have been obvious to provide containers of additives disclosed by Hedrick to produce desired results.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanor as applied to claim 8 above, and further in view of US 5,405,330 to Zunitch et al. (hereinafter Zunitch).
The applicator of Kanor is a hypodermic syringe 13 (col.4, lines 58-63). Kanor does not teach that the syringe has a pivoting head. Zunitch discloses a syringe for dispensing a medicant to a patient (col.9, lines 24-32) wherein the syringe includes a pivoting head 166. See col.4, line 68 to col.5, line 3; Fig.2.
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It would have been obvious to one of ordinary skill in the art to substitute the syringe of Zunitch for that of Kanor, as the syringe of Zunitch can rotate from the linear embodiment of Fig.1 that replicates the syringe of Kanor, to one where the head can be rotated to a desired angle in order to prevent excessive deflection of the needle relative to the barrel and breakage of the syringe during use. See col.1, lines 11-20.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanor and Hedrick as applied to claim 15 above, and further in view of US 2005/0255096 to Poder (hereinafter Poder).
The combination of Kanor with Hedrick discloses that a tissue disaggregation agent can be added with other solutions such as buffered/unbuffered saline and that the disaggregation agent may be any disaggregation agent known to one of skill in the art, including enzymes such as trypsin (paras [0096-0097] of Hedrick). While the liquids are provided within containers, the combination does not explicitly disclose a container having a first and second compartment separated by a breakable seal, the first containing water and second a lyophilized enzyme powder.
Poder discloses a combination treatment comprising a container with two solutions in separate chambers with a breakable seal (para [0037]) in which one solution is generally water and the other is a lyophilized product (para [0035]). At the time of the invention it would have been obvious to one of ordinary skill in the art to substitute the separate containers of solutions in the combination with a single container having chambers separated by a breakable seal as taught by Poder, as doing so permits long-term storage and mixing immediately prior to use to allow for a stable formulation. See para [0037].
Allowable Subject Matter
Claims 21-27 and 29-37 are allowed.
The following is an examiner’s statement of reasons for allowance: Neither Hedrick nor Kanor teach or suggest a disintegrating member that exerts a compression and rotational force on the tissue and also that does not contact the tissue. Kanor teaches compression and rotational force from a disintegrating member that contacts the tissue. While Hedrick discloses various agitating means may be used such as “rocking, stirring, inversion, etc.” (para [0095]) that do not necessarily contact the tissue, these methods do not apply both compression and rotational force on the tissue.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 22 January 2026, with respect to claims 1-20 and 38, have been fully considered but they are not persuasive.
On pages 14-15 of the Response, Patent Owner states that “Kanor does not disclose a pestle that is actuatable to exert force directly on tissue” and that pestle of Kanor is merely a “holder for a screen, regardless of the terminology used in Kanor.” The broadest reasonable interpretation of a pestle is a mechanical device for grinding, pounding, or stamping something. It may or may not interact with a mortar. In Kanor, the element formed by the head and the screen attached thereto forms the pestle. This element is used for crushing and grinding (disaggregating) tissue against screens 36,37. It is a mechanical device for grinding. Thus, Kanor teaches an element that meets the broadest reasonable interpretation of a pestle.
The amendments to claim 21 and arguments related thereto on pages 12-15 overcome the rejections under 35 USC §251, 102, and 103 of claim 21 and the dependents thereof.
Conclusion
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 11,124,752 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to ELIZABETH MCKANE whose telephone number is
(571) 272-1275. The examiner can normally be reached on Mon-Thurs; 6:30 am -
4:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's
supervisor, Patricia Engle can be reached on 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELIZABETH L MCKANE/
Specialist, Art Unit 3991
Conferees:
/JOSEPH R KOSACK/Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991