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 .
Notes
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
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: “an ultrasound imaging unit” in claim 1. The limitation of claim 1 meets the three-prong test as follows: (A) the generic placeholder: unit. (B) functional language: ultrasound imaging. (C) generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
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.
Claims 1-11 are 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.
Independent claim 1 recites the limitation "an ultrasound imaging unit," 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 “an ultrasound imaging unit” 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 “unit” coupled with functional language “ultrasound imaging” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term "unit" is not limited to a specific structure for performing the recited function(s). The term "unit" 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 an ultrasound imaging unit coupled to a bioreactor (see paragraph 38 of the application publication). However, Applicant’s disclosure is silent as to the structure that comprise the claimed ultrasound imaging unit (i.e., what structure does the ultrasound imaging unit comprise?). As such, said limitation fails to comply with the written description requirement.
Claims 2-11 are included in this rejection by virtue of their dependency upon a rejected base claim.
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 1-11 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.
Regarding claim 1, claim limitation “an ultrasound imaging unit” 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 “an ultrasound imaging unit” 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 “unit” coupled with functional language “ultrasound imaging” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term "unit" is not limited to a specific structure for performing the recited function(s). The term "unit" 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 an ultrasound imaging unit coupled to a bioreactor (see paragraph 38 of the application publication). However, Applicant’s disclosure is silent as to the structure that comprise the claimed ultrasound imaging unit (i.e., what structure does the ultrasound imaging unit 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.
Claims 2-11 are included in this rejection by virtue of their dependency upon a rejected base claim.
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 1-3, 9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Green et al. (already of record, US 2013/0177972; hereinafter “Green”).
Regarding claim 1, Green discloses a bioreactor assembly comprising: a housing defining an interior chamber (FIG. 1A: chamber defined by vessel walls; [0091]); a lid assembly removably coupled to the housing and enclosing the interior chamber (vessel maybe coupled to a lid; [0091]); a gimbal assembly disposable within the interior chamber, the gimbal assembly comprising: a cradle configured to hold an organ or organ scaffold (organ support structure on which a substitute organ 18 is shown; see [0091], FIG. 1A); and an arm assembly configured to move the cradle between a plurality of positions (robot arm adapted to move the organ support structure; [0148]. [0190]-[0191]; the robot arm is fully capable of moving the support structure between a plurality of positions); and an ultrasound imaging unit positioned to capture volumetric and/or spatial data of the organ or organ scaffold (ultrasound imaging coupled to the chamber/vessel for monitoring of contents inside the chamber/vessel ([0388]).
Regarding claim 2, Green further discloses wherein the lid assembly defines an injection tool access port for receiving an injection tool therethrough (FIG. 1A: a lid comprising at least two ports of the lid portion of the vessel; [0091]).
Regarding claim 3, Green further discloses wherein the lid defines one or more fluidic pathways therethrough extending from an exterior facing inlet port to an interior chamber facing inlet port (FIG. 1A: a lid comprising at least two ports of the lid portion of the vessel; [0010], [0091]).
Regarding claim 9, Green further discloses wherein the arm assembly comprises a tissue mount configured to receive and support at least a portion of the organ or organ scaffold (arm assembly supports the organ support structure and thus the organ or organ scaffold). Furthermore, it is noted that organ and organ scaffold are material worked on and not elements of the claimed bioreactor assembly. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115.
Regarding claim 11, Green further discloses wherein one or more sensors positioned within at least one of the lid assembly or the housing, wherein the one or more sensors are selected from the group consisting of a pressure sensor, a pH sensor, a turbidity sensor, a dissolved gas sensor, and a temperature sensor (see [0012], [0017]).
Therefore, Green meets and anticipates the limitations set forth in claims 1-3, 9 and 11.
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 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Green as applied to claim 1 above, and further in view of Uemura et al. (already of record, US 7,112,441; hereinafter “Uemura”).
Regarding claim 4, modified Green discloses the bioreactor assembly of claim 1. Modified Green does not explicitly disclose wherein the arm assembly comprises a first joint assembly configured to rotate the cradle about a first rotational axis and a second joint assembly configured to rotate the cradle about a second rotational axis different from the first rotational axis. Uemura discloses a bioreactor assembly comprising a gimbal assembly disposable within an interior chamber, the gimbal assembly comprising: a cradle configured to hold an organ or organ scaffold (FIG. 1: vessel 2; col. 4, ll. 8-11); an arm assembly configured to move the cradle between a plurality of positions (FIG. 1: Klinostat 1; col. 4, ll. 8-11); and a first joint assembly configured to rotate the cradle about a first rotational axis (FIG. 1: frame 5 rotate around axis 4a; col. 4, ll. 22-28) and a second joint assembly configured to rotate the cradle about a second rotational axis different from the first rotational axis (FIG. 1: frame 7 rotate around axis 6a; col. 4, ll. 22-28). In view of Uemura, 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 gimbal assembly of Green with the gimbal assembly of Uemura. One of ordinary skill in the art would have made said modification because Uemura discloses that the gimbal assembly enhances the cell culture process (see Uemura at col. 4, ll. 35-48).
Regarding claim 5, modified Green further disclose wherein the arm assembly comprises a first motor coupled to the first joint assembly (Uemura at FIG. 1: motor 4 with frame 5; col. 4, ll. 23-25) and a second motor coupled to the second joint assembly (FIG. 1: motor 6 with frame 7; col. 4, ll. 25-27), wherein each motor is independently operable from one another (FIG. 1; col. 4, ll. 23-27).
Regarding claim 6, modified Green discloses the claimed invention except for the rearrangement of the arm assembly to be coupled to the lid assembly. However, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date to have rearranged the arm assembly of modified Green such that the arm assembly is coupled to the lid assembly, since it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art (see MPEP § 2144.04 VI. C.). One would have been motivated to have rearranged the arm assembly unit to be coupled to the lid assembly for the purpose of ease of access and removal of the arm assembly from the housing.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Green as applied to claim 1 above.
Regarding claim 7, Green discloses the bioreactor assembly according to claim 1 as set forth above. Green discloses the claimed invention except for the rearrangement of the ultrasound imaging unit to be coupled to the lid assembly. However, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date to have rearranged the ultrasound imaging unit such that the ultrasound imaging unit is coupled to the lid assembly of Green, since it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art (see MPEP § 2144.04 VI. C.). One would have been motivated to have rearranged the ultrasound imaging unit to be coupled to the lid assembly for the purpose of ease of access and removal of the ultrasound imaging unit from the housing.
Allowable Subject Matter
Claims 8 and 10 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that the limitation “an ultrasound imaging unit” is described by the paragraphs [0063]-[0064], [0095]-[0101], and [0106]-[0111]) of the Applicant’s disclosure. Applicant further argues that “a person having ordinary skill in the art would recognize the claimed ultrasound imaging unit and would have understood the inventor to be in possession of the claimed invention at the time of filing,” (Remarks page 1).
Examiner respectfully disagrees. 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 “an ultrasound imaging unit” 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 “unit” coupled with functional language “ultrasound imaging” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term "unit" is not limited to a specific structure for performing the recited function(s). The term "unit" is considered to be non-structure modifier that fails to recite sufficiently definite structure, material or acts to perform the claimed function. Accordingly, the scope of said limitation is limited to the corresponding structure disclosed in the specification and equivalents thereof. The instant specification, as originally filed, discloses an ultrasound imaging unit coupled to a bioreactor (see paragraph 38 of the application publication). However, Applicant’s disclosure is silent as to the structure that comprise the claimed ultrasound imaging unit (i.e., what structure does the ultrasound imaging unit comprise?). It is noted the Applicant does not refute that said limitation invokes 35 U.S.C. 112(f), nor does Applicant identify any specific structure either in the cited paragraphs or as understood by one of ordinary skill in the art that corresponds to the claimed “ultrasound imaging unit” and performs the recited function. None of the cited paragraphs adequately describe as to the structure of the ultrasound imaging unit. Moreover, it is not sufficient for Applicant to merely assert that one of ordinary skill in the art would know what structure to use to accomplish the claimed function. Rather, in section 35 U.S.C. 112(f), the inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing that structure. Here, Applicant has not identified any specific structure within the cited paragraphs. As such, Applicant’s argument is not persuasive.
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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