DETAILED ACTION
The Art Unit location of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Art Unit 1799.
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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 45-53, in the reply filed on 5/24/2026 is acknowledged.
Claims 54-64 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/24/2026.
Information Disclosure Statement
The information disclosure statement dated 12/26/2023 has been considered and made of record.
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:
“a cell delivery unit” in claim 45;
“a reciprocating member” in claim 46;
“an element or a member configured for inducing vortexing, shaking or stirring, wherein the member is not a blade or a set of blades” in claim 47;
“a storage unit” in claim 48;
“a reciprocating unit” in claim 49.
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 § 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.
Claim 46 is 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 46 depends from claim 45 and recites “a cell isolation chamber” and “a delivery unit”. Claim 45 already recites “a cell isolation chamber” and “a delivery unit”. As a result, it is not clear if these are additional structures or the same structures recited in claim 46. Claim 46 will be treated on its merits as though the claim elements in question are the same claim elements as recited in claim 45. Clarification and/or correction is requested.
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)(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 45-50, 52 and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tremolada (US 2013/0123747) (Attached PTO-892).
With respect to claim 45, the reference of Tremolada discloses:
A device (Fig. 10) comprising a cell isolation chamber (CIC)(washing and isolation chamber)(1) detachably associated with a cell delivery unit (syringe)(12) (Note: This claim element is considered to invoke 35 USC 112(f), the disclosed corresponding structure is a syringe device), the CIC being adapted to receive a tissue to be mechanically and/or enzymatically manipulated to separate therefrom cells or cell populations, wherein the device is configured to allow cells isolated from the tissue in the cell isolation chamber to gravitationally collect in the detachable cell delivery unit, wherein the delivery unit is configured for delivery of the isolated cells in vivo or in vitro (The disclosed device is structurally capable of being used in this manner).
With respect to claims 46, 48 and 49, the device of the reference of Tremolada discloses that the delivery unit (syringe)(12) is detachably connected to the CIC (chamber)(1) through a valve assembly (9) wherein the delivery unit (syringe)(12) has a main body and a reciprocating member (plunger rod) (Note: This claim element is considered to invoke 35 USC 112(f), the disclosed corresponding structure is a syringe device which would include a main body and reciprocating plunger rod.)
With respect to claim 47, the reference of Tremolada discloses that the device can include an element or member for inducing vortexing, shaking or stirring (¶[0142]-[0148]) (Note: This claim element is considered to invoke 35 USC 112(f), the disclosed corresponding structure is discussed in ¶[0017]-[0020]of the instant specification which includes the same structures as discussed by the reference of Tremolada.)
With respect to claim 50, the reference of Tremolada discloses the barrel of the syringe device (12) has at least two openings, one of said opening being positioned along a path of material communication with said CIC and another at one end of the barrel being opposite to the plunger path (Fig. 10).
With respect to claims 52 and 53, the reference of Tremolada discloses the delivery unit (syringe)(12) is connected with the CIC through a connector member (9) which include “luer locks” (¶[0137]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Tremolada (US 2013/0123747) (Attached PTO-892) in view of Huang (US 2016/0361476) (Attached PTO-892) and Schroeder et al. (WO 2011/006056) (Attached PTO-892).
The reference of Tremolada has been discussed above with respect to claim 45.
Claim 51 differs by reciting that a tubular body of the delivery unit (syringe) is provided with a membrane or filter.
The reference of Huang discloses that it is known in the art of processing and isolating cells to filter the cells provided the collection/delivery syringe (326) (¶[0135]).
The reference of Schroeder et al. discloses that it is known in the art to provide an adipose cell delivery device (syringe)(14) with a filter (24) disposed in the syringe body (Fig. 7).
In view of these teachings and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the dispensing syringe of the system of the reference of Tremolada with a filter for the known and expected result of providing an art recognized means of ensuring the correct size of cells are delivered from the syringe device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The reference of Fojtik (US 2011/0224642) (Attached PTO-892) is cited as prior art which pertains to a syringe device with two ports.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB
Prosecution Insights