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.
Priority
Receipt is acknowledged of certified copies of papers (CHINA 202011587236.1 12/29/2020) required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement dated 6/28/2023 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 fluid guiding structure” in claim 1.
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 11-14 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 11 is indefinite because it is not clear if the recited “two side diverting blocks” and “one central fluid diverting block” are the same or different from those recited in claim 2. Clarification and/or correction is requested.
In claims 12 and 13, “the side diverting block” lacks clear antecedent basis. Note: Claim 11 recites two side diverting blocks. Which of the two is being referenced? Clarification and/or correction is requested.
Claim 14 is indefinite because the claim lacks antecedent basis for the outlet channel having flow diverting blocks. The previous claims only recite flow diverting blocks with respect to the inlet channel. 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (CN 208250333 and corresponding English language machine translation) in view of Chander et al.(US 2016/0272934).
With respect to claim 1, the reference of Yang et al. discloses:
A flow electrotransfection device (Figs. 13 and 15), comprising:
a chamber (electroporation chamber)(4) for fluid to flow though;
a liquid inlet channel (inlet pipe, bracket and buffer area)(7, 8, 9) connected to the chamber; and
a liquid outlet channel (outlet pipe, bracket and buffer area)(1, 2, 3) connected to the chamber, including an electrode module (first and second planar electrodes)(11 and 12) for applying an electric field to fluid in the chamber.
While the reference of Yang et al. is concerned with providing uniform flow through the chamber (page 4, paragraphs 1-5; page 8, last 3 paragraphs; and page 12, paragraphs 1-7), claim 1 differs by reciting that the device includes a fluid guiding structure for evening out flow velocities of fluid flowing through different zones in the chamber.
The reference of Chander et al. discloses that it is known in the art to provide baffles (38) (¶[0081) when providing a flow of a liquid into a chamber so as to create an even flow distribution into a perfusion chamber.
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 inlet area of the flow device of the reference of Yang et al. with baffles for the known and expected result of providing an art recognized means for improving and providing uniform flow of liquid into the flow chamber of the electroporation device. Note: The baffles suggested by the reference of Chander et al. are considered to meet the structure of the fluid guiding structure since the diverting blocks of the instant disclosure appear to be the same as the baffles of the reference of Chander et al.
With respect to claims 2-10, while the combination of the references as discussed above with respect to claim 1 suggest using baffles or diverting blocks within the inlet area of the device, the references are silent with respect to the shapes, sizes, spacings, etc. of the baffles. However, in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to determine the optimal shapes, sizes, spacings of the diverting blocks through routine experimentation while ensuring the desired uniform flow of liquid through the chamber is achieved.
With respect to claim 11, the reference of Yang et al. discloses that the device includes an electrode bracket (10) and two planar electrodes (11 and 12).
With respect to claims 12-14, the reference of Yang et al. discloses the inlet tube includes buffer area (9) and the outlet tube includes buffer area (3). Use of baffles on both ends of the chamber would have been obvious for ensuring even distribution of flow through the chamber.
With respect to claim 15, the structure resulting from the combination of the references as discussed above with respect to claims 1 and 14 would result with the fluid guiding structure or baffles provided within the inlet and/or outlet channels.
With respect to claims 16 and 18, the structure resulting from the combination of the references as discussed above with respect to claim 1 would result with the fluid guiding structure including one or more baffles or blocks or blades.
With respect to claims 17 and 19, while the combination of the references as discussed above with respect to claims 1 and 18 suggest using baffles or diverting blocks within the inlet area of the device, the references are silent with respect to the shapes, sizes, spacings, etc. of the baffles. However, in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to determine the optimal shapes, sizes, spacings of the diverting blocks through routine experimentation while ensuring the desired uniform flow of liquid through the chamber is achieved.
With respect to claim 20, the reference of Yang et al. discloses that the device includes two planar electrodes (11 and 12).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The references of Szita et al. (US 2015/0231634) and Zhou et al. (CN 104190887 is cited as prior art that pertains to the use of baffles to provide a uniform flow within a flow device.
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