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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-21 in the reply filed on June 8, 2026 is acknowledged.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Applications No. 63/185,650 and 63/227,210, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claim 1 requires a microfluidic lid assembly comprising a layer with apertures, and microfluidic channels. However, provisional Application No. 63/185,650 and 63/227,210 do not provide support for the claimed microfluidic lid assembly comprising a layer with apertures, and microfluidic channels. Accordingly, this application has been given the effective filing date of 21 January 2022.
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: “one or more first temperature control modules” in claim 18; and “one or more second temperature control modules” in claim 18; and “a gas supply system” in claim 21.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 21 recites the limitation "a gas supply system," however, said limitation fails to comply with written description requirement. 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. Claim limitation “a gas supply system” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “system” coupled with functional language “to provide at least one gas to the microfluid structure” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term "system" is not limited to a specific structure for performing the recited function(s). The term "system" is considered to be non-structure modifier that fails to recite sufficiently definite structure, material or acts to perform the claimed function. The instant specification, as originally filed, discloses a gas supply system configured to provide at least one gas to the microfluid structure (see paragraph [0366] of the application publication). However, Applicant’s disclosure is silent as to the structure that comprise the claimed gas supply system (i.e., what structure does the gas supply system comprise?). As such, said limitation fails to comply with the written description requirement.
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 14, 20 and 21 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 14 recites the limitation "wherein the predetermined range of motion is within an interior diameter of a top end of a guide element" in lines 5-7. It is unclear if the guide element is one among the guide elements recited earlier in the claim or is an additional guide element.
Claim 20 recites the limitation "a titer module" in line 3. However, Applicant’s disclosure is silent as to the structure that comprise the claimed titer module (i.e., what structure does the titer module comprise?). Further clarification is requested and appropriate correction is required.
Regarding claim 21, claim limitation “a gas supply system” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. 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. Claim limitation “a gas supply system” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “system” coupled with functional language “to provide at least one gas to the microfluid structure” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term "system" is not limited to a specific structure for performing the recited function(s). The term "system" is considered to be non-structure modifier that fails to recite sufficiently definite structure, material or acts to perform the claimed function. The instant specification, as originally filed, discloses a gas supply system configured to provide at least one gas to the microfluid structure (see paragraph [0366] of the application publication). However, Applicant’s disclosure is silent as to the structure that comprise the claimed gas supply system (i.e., what structure does the gas supply system comprise?). Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Appropriate correction is required.
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 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Homs Corbera et al (US 2020/0299631; hereinafter “’631”).
Regarding claims 1-5, it is noted that while the invention contains a sample container, the sample container is not positively recited in claims 1-9.
Regarding claim 1, ‘631 discloses a system comprising: a microfluidic lid assembly configured to create an air-tight seal above a sample container having reservoirs ([0049]), the microfluidic lid assembly comprising: guide elements (FIGS. 2 and 4A: lid (1) having zones (11) guiding light to a sample container; [0081]-[0082]); a layer with apertures configured to align underneath the guide elements (FIGS. 2 and 4A: plate (9) having orifices (91); [0096], [0116]); and a microfluidic structure with through-holes configured to align underneath the apertures of the layer, wherein the microfluidic structure comprises: gas inlets configured to fluidly couple with one or more fluid sources (FIGS. 2 and 4A: microfluidic panel (2) defining gas or liquid fluidic connections of a microfluidic device (100); [0083]); and microfluidic channels configured to fluidly couple the gas inlets to the reservoirs of the sample container ([0083]).
Regarding claim 2, ‘631 further discloses wherein the microfluidic structure is configured to individually seal each of the reservoirs of the sample container ([0049], [0083]-[0085] and [0088]).
Regarding claim 3, ‘631 further discloses wherein each microfluidic channel is configured transport a controlled gas concentration to an individually sealed one of the plurality of reservoirs ([0049] and [0083]).
Regarding claim 4, ‘631 further discloses wherein a first subset of the microfluidic channels is configured to convey one or more of gaseous oxygen, nitrogen, or carbon dioxide to the reservoirs (microfluidic panel (2) includes a plurality of microfluidic channels connecting different wells, and a first subset of said microfluidic channels are fully capable “to convey one or more of gaseous oxygen, nitrogen, or carbon dioxide to the reservoirs”). Furthermore, the limitation “to convey one or more of gaseous oxygen, nitrogen, or carbon dioxide to the reservoirs” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114).
Regarding claim 5, ‘631 further discloses wherein a second subset of the microfluidic channels is configured to convey liquid reagents to the reservoirs (microfluidic panel (2) includes a plurality of microfluidic channels connecting different wells, and a first subset of said microfluidic channels are fully capable “to convey liquid reagents to the reservoirs”). Furthermore, the limitation “to convey liquid reagents to the reservoirs” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114).
Regarding claim 6, ‘631 further discloses wherein the microfluidic structure further comprises additional microfluidic channels configured to convey a gas away from the reservoirs (a subset of the microchannels can be employed to remove materials from the reservoirs). Furthermore, the limitation “to convey a gas away from the reservoirs” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114).
Regarding claim 7, ‘631 further discloses wherein the guide elements and the layer form an integral unit (elements of the system can be permanently assembled (see [0103]).
Regarding claim 8, ‘631 further discloses wherein the guide elements are disposed on a guide structure that is coupled to the layer (FIGS. 2 and 4A: lid (1) having zones (11) guiding light to a sample container; [0081]-[0082]).
Regarding claim 9, ‘631 further discloses wherein the microfluidic lid assembly is configured to be adhered to the sample container with an adhesive (lid (1) of ‘631 is structurally the same as the instant microfluidic lid assembly, and thus considered to be fully capable to be adhered to the sample container with an adhesive). Furthermore, it is noted that while the claim contains a sample container, the sample container is not positively recited in instant claim 9.
Therefore, ‘631 meets and anticipates the limitations set forth in claims 1-9.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pfost et al (US 6,485,690; hereinafter “Pfost”).
Regarding claim 1, it is noted that while the invention contains a sample container, the sample container is not positively recited in claim 1.
Regarding claim 1, Pfost discloses a system comprising: a microfluidic lid assembly configured to create an air-tight seal above a sample container having reservoirs, the microfluidic lid assembly comprising: guide elements (FIGS. 10-18: openings (20’) of cover layer (12’)); a layer with apertures configured to align underneath the guide elements (gasket with openings arranged below middle distribution layer (14’); col. 4, ll. 58-59; col. 6, ll. 22-26; col. 7, ll. 59-60 col. 11, ll. 32-37); and a microfluidic structure with through-holes configured to align underneath the apertures of the layer (FIG. 10: apertures of layer (14’) aligned below opening 20’), wherein the microfluidic structure comprises: gas inlets configured to fluidly couple with one or more fluid sources (col. 8, ll. 48-51); and microfluidic channels configured to fluidly couple the gas inlets to the reservoirs of the sample container (FIG. 10: microchannels (26’)).
Therefore, Pfost meets and anticipates the limitations set forth in claim 1.
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 10-13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over ‘631 as applied to claim 1 above.
Regarding claim 10, ‘631 discloses the system according to claim 1. ‘631 disclose the claimed aperture but does not explicitly disclose wherein the apertures are slits in the layer. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the apertures of the layer of ‘631 to comprise slits, since it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination (see MPEP 2144.04 IV.B.).
Regarding claim 11, ‘631 does not explicitly disclose wherein the layer comprises a resilient polymer material. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the layer of ‘631 with any material including the claimed material, since it has been held to be within the ordinary skill of worker in the art to select a known material on the basis of its suitability for the intended use (In re Leshin, 125 USPQ 416 (CCPA 1960; MPEP § 2144.07).
Regarding claim 12, ‘631 discloses a sample container assembly, comprising: the sample container comprising the reservoirs (FIGS. 4A-4B: multi-well plate (7); [0104]); and the microfluidic structure, wherein a bottom surface of the microfluidic structure is coupled to a top surface of the sample container (FIGS. 4A-4B: microfluidic panel (2) is coupled to a top surface of the multi-well plate). ‘631 does not explicitly disclose wherein the bottom surface of the microfluidic structure is adhered to the top surface of the sample container. However, ‘631 does disclose wherein the components lid is coupled/bonded to the top surface of the sample container (see FIGS. 4B and 5; [0090], [0091], [0104]). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupling between the lid and sample container of ‘631 such that the bonding is be adhesive to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known coupling/bonding means for another for the predictable result of bonding between two components.
Regarding claim 13, ‘631 further discloses wherein a top surface of the microfluidic structure is adhered to a bottom surface of the layer (microfluidic pane (2) is formed of double-sided adhesive tape adapted to be coupled to other components of the system including layer (9); see FIGS. 4A-4B; [0083], [0088]).
Regarding claim 21, ‘631 further discloses a control system, comprising: sensors configured to acquire measurement parameters associated with the sample container assembly (detection and biodetection devices coupled to samples within the sample container assembly; [0049], [0052], [0102], [0116]). a gas supply system configured to provide at least one gas to the microfluid structure ([0116]); and a controller configured to process the acquired measurement parameters and control the gas supply system based upon the processed measurement parameters (different parameters such as pH, temperature and perfusion rate are controlled in real-time, and thus the system of ‘631 intrinsically includes a controller to automate the process of controlling the parameters; see [0049], [0052], [0102], [0116]).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Pfost as applied to claim 1 above.
Regarding claim 12, Pfost discloses the system according to claim 1. Pfost further discloses a sample container assembly, comprising: the sample container comprising the reservoirs (FIG. 10: well plate layer (16’) having wells); and the microfluidic structure, wherein a bottom surface of the microfluidic structure is bonded to a top surface of the sample container (layers of the system can be bonded using gasket or sealing means; col. 6, ll. 22-26). Pfost does not explicitly disclose wherein bonding between layers of the system is formed by adhesive material. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bonding between the layers of the system by employing adhesive material to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known bonding means for another for the predictable result of bonding layers to one another.
Regarding claim 13, Pfost discloses wherein a top surface of the microfluidic structure is bonded to a bottom surface of the layer (layers of the system can be bonded using gasket or sealing means; col. 6, ll. 22-26). Pfost does not explicitly disclose wherein bonding between layers of the system is formed by adhesive material. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bonding between the layers of the system by employing adhesive material to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known bonding means for another for the predictable result of bonding layers to one another.
Allowable Subject Matter
Claims 14 and 20 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.
Claims 15-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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