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 .
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 of Group I, Claims 1-11, in the reply filed on 12/1/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/1/2025.
Priority
Receipt is acknowledged of certified copies (EP 20211094.6 12/01/2020) of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements dated 6/1/2023 and 1/19/2026 have 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 mixing device” in claim 7.
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.
Claims 2, 4-9 and 11 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.
In claim 2, use of the language “particularly” renders the claim indefinite because it is not clear if the claim is limited to the “particularly” language. Clarification and/or correction is requested.
In claim 4, use of the language “particularly” renders the claim indefinite because it is not clear if the claim is limited to the “particularly” language. Clarification and/or correction is requested.
In claim 5, use of the language “particularly” renders the claim indefinite because it is not clear if the claim is limited to the “particularly” language. Clarification and/or correction is requested.
In claim 6, “the second purification material” lacks antecedent basis. Note: Claim 6 depends from claim 1 rather than claim 3. Clarification and/or correction is requested.
In claim 7, “the second purification material” lacks antecedent basis. Note: Claim 6 depends from claim 1 rather than claim 3. Clarification and/or correction is requested.
In claim 8, use of the language “particularly” renders the claim indefinite because it is not clear if the claim is limited to the “particularly” language. Clarification and/or correction is requested.
In claim 9, use of the language “particularly” renders the claim indefinite because it is not clear if the claim is limited to the “particularly” language. Clarification and/or correction is requested.
In claim 11, use of the language “particularly” renders the claim indefinite because it is not clear if the claim is limited to the “particularly” language. Clarification and/or correction is requested.
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.
Claims 1-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (US 2014/0315303) (Attached PTO-892) in view of Yang (CN 107174678 and corresponding English language machine translation) (Attached PTO-892).
With respect to claim 1, the reference of Huang discloses:
A device (500)(Figs. 3A and 11) for preparing a cell suspension comprising
a. an enzyme reservoir (Chamber 1)(¶[0177]) for containing an enzyme solution (dissociation solution) capable of digesting components of a tissue sample to obtain a cell suspension,
b. a first purification compartment (Chamber 2) for receiving a first purification material capable of binding and/or retaining at least one component of the cell suspension (mesh 1, mesh 2), wherein the first purification compartment (Chamber 2) is in fluid connection or can be brought into fluid connection with the enzyme reservoir (Chamber 1).
Claim 1 differs by reciting the additional limitation:
c. a syringe comprising a barrel defining a barrel compartment and a piston which is movably arranged in the barrel compartment, wherein the syringe comprises a syringe inlet connected to the barrel compartment, and wherein the syringe comprises a syringe outlet for dispensing the cell suspension from the barrel compartment; and
d. wherein the device comprises a flow path from the enzyme reservoir via the first purification compartment to the syringe inlet.
The reference of Huang discloses that it is known to connect a syringe to the outlet port of the device to collect the processed cell suspension (Fig. 11).
The reference of Yang discloses that it is known in the art to employ a syringe (6)(Fig. 2) comprising a barrel defining a barrel compartment and a piston which is movably arranged in the barrel compartment, wherein the syringe comprises a syringe inlet connected to the barrel compartment, and wherein the syringe comprises a syringe outlet for dispensing the cell suspension from the barrel compartment.
In view of these disclosures and in the absence of a showing of unexpected results, it would have been obvious to communicate a syringe as disclosed by the reference of Yang in communication with port 5 of the device of Huang for the known and expected result of providing an art recognized syringe for collection and dispensing of a processed cell suspension while providing the advantages (pages 6 and 7 of the translation) of using the syringe of Yang to collect and dispense the cell suspension.
With respect to claim 2, the reference of Huang discloses at least one valve (Pinch Clamp 2, Clamp 1, Clamp 3) (Fig. 11) arranged in said flow path between the enzyme reservoir (Chamber 1) and the syringe inlet (port 5, female luer connector).
With respect to claim 3, the reference of Huang discloses a second purification compartment (Chamber 4) for receiving a second purification material capable of binding and/or retaining at least one component of the cell suspension (mesh 3), wherein the second purification compartment (Chamber 4) is arranged in said flow path between the first purification compartment (Chamber 2) and the syringe inlet (port 5, female luer connector).
With respect to claim 4, the reference of Huang discloses a reservoir (Chamber 4) which is structurally capable of storing a buffer, wherein the reservoir (Chamber 4) is in fluid connection or can be brought into fluid connection with said flow path between the enzyme reservoir (Chamber 1) and the syringe inlet (port 5, female luer connector) to mix said buffer with the cell suspension.
With respect to claim 5, the reference of Huang discloses a waste reservoir (Chamber 3) which is in fluid connection or can be brought into fluid connection with said flow path between the enzyme reservoir (Chamber 1) and the syringe inlet (port 5, female luer connector).
With respect to claim 8, the reference of Yang discloses that it is known in the art to provide a surgical tool (1, 5) (Fig. 1) in communication with the components (3) of a processing system. In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ a sampling device as suggested by the reference of Yang in communication with the processing device of Huang for the known and expected result of providing an art recognized means for obtaining a sample to be processed within the device.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Huang (US 2014/0315303) (Attached PTO-892) in view of Yang (CN 107174678 and corresponding English language machine translation) (Attached PTO-892) taken further in view of Guest et al. (US 2020/0032197) (IDS dated 6/1/2023).
The combination of the references of Huang and Yang has been discussed above with respect to claim 1.
Claim 6 differs by reciting that the device includes a magnet arranged adjacent to the flow path between the enzyme reservoir and the syringe inlet for interacting with magnetic purification material to be used within the device.
The reference of Guest et al. discloses that the use of magnetic particles and a magnetic field is known in sample processing devices (¶[0080]-[0083]).
In view of this teaching 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 device of the reference of Huang with a magnet for the known and expected result of providing an art recognized means for facilitating purification of the sample within the device as evidenced by the reference of Guest et al.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Huang (US 2014/0315303) (Attached PTO-892) in view of Yang (CN 107174678 and corresponding English language machine translation) (Attached PTO-892) taken further in view of Shani et al. (US 2018/0155691) (IDS dated 6/1/2023).
The combination of the references of Huang and Yang has been discussed above with respect to claim 1.
With respect to claim 7, while the reference of Huang discloses the device can include a mixing chamber (Chamber 2 or Chamber 4) arranged in said flow path between the enzyme reservoir (Chamber 1) and the syringe inlet (port 5, female luer connector), the reference does not specifically disclose a mixing device.
The reference of Shani et al. discloses that it is known in the art to provide a sample processing device with a mixing device (5,7) (Fig. 1).
In view of this teaching 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 device of the reference of Huang with a mixing device for the known and expected result of providing an art recognized means for facilitating mixing within the device as desired by the reference of Huang and as evidenced by the reference of Shani et al.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (US 2014/0315303) (Attached PTO-892) in view of Yang (CN 107174678 and corresponding English language machine translation) (Attached PTO-892) taken further in view of Sumida et al. (US 2015/0112269) (IDS dated 6/1/2023).
The combination of the references of Huang and Yang has been discussed above with respect to claim 1.
While the combination of the reference discussed above with respect to claim 1 encompasses a device that includes a syringe with a needle (7-1 of Yang), claim 10 differs by reciting that the syringe of the device includes an injector with a plurality of hollow needles.
The reference of Sumida et al. discloses that it is known in the art to employ a plurality of hollow needles (10c) (Figs. 2A and 2B) with a syringe (12) as an alternative to the use of a single needle (¶[0007]).
In view of this teaching 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 syringe of the modified primary reference with a plurality of hollow needles when injecting the processed sample for intradermal injection.
With respect to claim 11, the reference of Sumida et al. discloses that the needles can have a length of 100 µm to 2000 µm (¶[0031]).
Allowable Subject Matter
Claim 9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 9 would be allowable because the prior art of record fails to teach or fairly suggest a device, in the claimed environment or scope of claim, that includes a pump inlet arranged in the enzyme reservoir, wherein the pump inlet is configured to be connected to a vacuum pump to generate a vacuum in the enzyme reservoir, such that a portion of skin of a subject is sucked into the enzyme reservoir by the vacuum if the portion of skin is placed on said opening of the enzyme reservoir, and wherein the surgical tool comprises at least one movable blade assembly configured to cut off the portion of skin.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The reference of Tremolada (US 2013/0123747) (Attached PTO-892) is cited as prior art that pertains to a sample processing system includes a processing chamber.
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