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 1-10, in the reply filed 5/28/2026 is acknowledged.
Claims 19 and 20 have been cancelled in the reply filed 5/28/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the fixed part claimed in claim 1 and claim 22 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the term Nikon™ in the specification ([0076]), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 4 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, claims 4-5 have not been further treated on the merits.
Claims 7-10 and 21-22 are objected to because of the following informalities:
The claims as written skip claim 6 in the claim numbering. It is suggested to amend claims 7-10 to be numbered claims 6-9 and amend claim dependencies accordingly.
In claim 9, “the micro controller” in line 2 should read “the microcontroller” for consistency with preceding limitations, preceding claims, or the written disclosure.
In claim 21, “at least a top surface of the mechanical input” in line 11 is a typographical error and should read “at least a top surface of the mechanical input.”
In claim 22, “horizontal axis relative to the fixed part” in line 4 is a typographical error and should read “horizontal axis relative to the fixed part.”
Appropriate correction is required.
Claim Interpretation
In claim 5, “an engagement panel” is interpreted as a surface of the fixed part or the movable part, evidenced by Fig. 3C in the drawings. See screws adapted to extend through the surface.
Claim Interpretation – 35 USC 112(f)
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 first fixation device configured to fix a first end of a graft in place relative to the base” in claim 1, lines 3-4;
interpreted as a clamp or an equivalent thereof, evidenced by [0051] in the written disclosure and Fig. 2 in the drawings.
“a second fixation device configured to fix a second end of the graft in place relative to the movable part” in claim 1, lines 5-6;
interpreted as a clamp or equivalent thereof, evidenced by [0051] in the written disclosure and Fig. 2 in the drawings.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
“means for driving the movable part” in claim 1, line 7, is not interpreted under 35 USC 112(f) because structure is provided by “mechanical input” in line 10.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-5, 7-10 and 21-22 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, it is unclear if the fixed part and the base are the same or different features. The limitation “a fixed part including a base” is inconsistent with the specification as written ([0050], “a movable part 20 positioned on top of a fixed part or a base 30”). A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty (MPEP § 2173.03). For examination on the merits, the fixed part and base will be interpreted as the same feature, as this is consistent with the specification.
Claims 2-5 and 7-10 are similarly rejected as the depend upon rejected claim 1.
Claim 21 is similarly rejected as it also recites the limitation “a fixed part including the base”.
Claim 22 is similarly rejected as it depends upon rejected claim 21.
Claim Rejections - 35 USC § 102
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.
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, 4, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luo et al. (CN 111187719 A) (hereinafter referred to as Luo, see PTO-892 – English machine translation provided and cited herein).
Regarding claim 1, Luo discloses a bioreactor (Fig. 2, force-electric coupling loading platform) adapted to be placed in a container with liquid media, the bioreactor comprising a fixed part including a base (Fig. 2, base 1 – see figures below) and a first fixation device (Fig. 4, left chuck 27) configured to fix a first end of a graft in place relative to the base ([0049], “left clamp 27 is used to clamp and fix the left end of the sample 10”),
a moveable part (Fig. 2, right clamping device 7) including a second fixation device (Fig. 4, right chuck 29) configured to fix a second end of the graft in place relative to the movable part ([0049], “right clamp 29 is used to clamp and fix the right end of the sample 10”), the moveable part mounted to slide relative to the fixed part so as to move the second end of the graft relative to the first end of the graft ([0049]), and
means for driving the movable part ([0018] driving device; Fig. 2, driving motor 13, driving helical gear 17, driven helical gear 18, ball screws 19, and right tension arm 5) to slide relative to the fixed part such that the second fixation device moves toward and away from the first fixation device to decrease or increase tension in the graft to thereby mechanically stimulate the graft ([0015], “driving device can drive…the right tension arm to move”), wherein the means for driving includes a mechanical input that extends upwardly to a point above the first fixation device and the second fixation device (Fig. 1, driving helical 17 is above the first fixation device and second fixation device) so that sliding of the movable part can be effected without undue disturbance of liquid media at a level above the first and the second fixation devices such that the graft is submerged but also at a level below at least a top surface of the
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mechanical input.
The preamble limitation “adapted to be placed in a container with liquid media” is merely a recitation of a purpose or intended use of the invention and has been given an appropriate patentable weight (MPEP § 2111.02 II).
The limitation “can be effected without undue disturbance of liquid media at a level above the first and the second fixation devices such that the graft is submerged but also at a level below at least a top surface of the mechanical input” is a limitation contingent on the sliding of the movable part and has been given an appropriate patentable weight (MPEP § 2111.04 II).
Regarding claim 4, Luo discloses the bioreactor of claim 1, wherein at least one of the first fixation device and the second fixation device is provided by a clamp that overlies a portion of the fixed part or the movable part ([0014], left and right clamping devices; Fig. 2 shows that left and right clamping devices overlies the fixed part).
Regarding claim 21, Luo discloses a bioreactor (Fig. 2, force-electric coupling loading platform) adapted to be placed in a container with liquid media, the bioreactor comprising a fixed part including a base (Fig. 2, base 1) and a first fixation device ([0049], “right clamp 29 is used to clamp and fix the right end of the sample 10”) configured to fix a first end of a graft in place relative to the base ([0049], “left clamp 27 is used to clamp and fix the left end of the sample 10”),
a moveable part (Fig. 2, right clamping device 7) including a second fixation device (Fig. 4, right chuck 29) configured to fix a second end of the graft in place relative to the movable part ([0049], “right clamp 29 is used to clamp and fix the right end of the sample 10”), the moveable part mounted to slide relative to the fixed part so as to move the second end of the graft relative to the first end of the graft ([0049]), and
a mechanical input that extends upwardly to a point above the first fixation device and the second fixation device (Fig. 1, driving helical 17 is above the first fixation device and second fixation device) so that sliding of the movable part can be effected without undue disturbance of liquid media at a level above the first and the second fixation devices such that the graft is submerged but also at a level below at least a top surface of the mechanical input.
The preamble limitation “adapted to be placed in a container with liquid media” is merely a recitation of a purpose or intended use of the invention and has been given an appropriate patentable weight (MPEP § 2111.02 II).
The limitation “can be effected without undue disturbance of liquid at a level above the first and the second fixation devices such that the graft is submerged but also at a level below at least a top surface of the mechanical input” is a limitation contingent on the sliding of the movable part and has been given an appropriate patentable weight (MPEP § 2111.04 II).
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.
Claims 2 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Luo.
Regarding claim 2, Luo discloses the bioreactor of claim 1, wherein the means for driving includes a drive system ([0018], driving device is a drive system as it comprises multiple parts) in which the mechanical input is provided by a worm structure (Fig. 2, driving helical gear 17 is a worm structure), and wherein the moveable part is mounted to move along a horizontal axis relative to the fixed part ([0014], right arm is horizontally mounted).
Luo is silent to the worm structure rotating about a vertical axis to cause a gear located in the fixed part to move a rack coupled to the moveable part.
Nonetheless, modifying the bioreactor of Luo such that the worm structure rotates about a vertical axis to cause a gear located in the fixed part to move a rack coupled to the moveable part would amount to merely rearrangement of parts, as such a modification would predictably result in the driving helical gear, i.e., the worm structure, providing a mechanical input to the moveable parts. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI).
The limitation “to cause a gear located in the fixed part to move a rack coupled to the moveable part” is directed toward the intended manner of operating the claimed worm structure and does not differentiate the claimed worm structure from the prior art worm structure because all structural limitations are taught in the prior art (MPEP § 2114 II). Claim 2 as written does not positively recite the gear located in the fixed part or the rack coupled to the moveable part, as they are directed towards materials or articles worked upon by the claimed apparatus and do not limit the claim which it depends upon (MPEP § 2115). Thus, the prior art worm structure would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 22, Luo discloses the bioreactor of claim 21, which the mechanical input is provided by a worm structure (Fig. 2, driving helical gear 17 is a worm structure), and wherein the moveable part is mounted to move along a horizontal axis relative to the fixed part ([0014], right arm is horizontally mounted).
Luo is silent to the worm structure rotating about a vertical axis to cause a gear located in the fixed part to move a rack coupled to the moveable part.
Nonetheless, modifying the bioreactor of Luo such that the worm structure rotates about a vertical axis to cause a gear located in the fixed part to move a rack coupled to the moveable part would amount to merely rearrangement of parts, as such a modification would predictably result in the driving helical gear, i.e., the worm structure, providing a mechanical input to the moveable parts. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI).
The limitation “to cause a gear located in the fixed part to move a rack coupled to the moveable part” is directed toward the intended manner of operating the claimed worm structure and does not differentiate the claimed worm structure from the prior art worm structure because all structural limitations are taught in the prior art (MPEP § 2114 II). Claim 22 as written does not positively recite the gear located in the fixed part or the rack coupled to the moveable part, as they are directed towards materials or articles worked upon by the claimed apparatus and do not limit the claim which it depends upon (MPEP § 2115). Thus, the prior art worm structure would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Luo as applied to claim 2 above, and further in view of Williams et al. (US 2013/0160577 A1) (hereinafter referred to as Williams, see PTO-892).
Regarding claim 3, Luo teaches the bioreactor of claim 2.
Luo is silent to the worm structure attached to the base with a screw configured to drive friction between the worm structure and adjacent components that resists reverse motion of the worm structure in response to tension developed in the graft.
However, Williams in the art of apparatuses for applying mechanical stimulation to biological samples teaches it is known in the art to use a screw to lock a sample grip in place ([0027]; Fig. 6 shows thumb screw 261 attached to a shaft and a chamber, i.e., a worm structure and a base).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bioreactor of Luo to incorporate a thumb screw, i.e., a screw, to attach the worm structure to the base for the purpose of locking the worm structure, i.e., driving a friction between the worm structure and adjacent components. This method for improving the device of Luo was known in the art.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Luo as applied to claim 2 above, and further in view of Wu et al. (CN 113913292 A) (hereinafter referred to as Luo, see PTO-892 – English machine translation provided and cited herein) and Tamayol et al. (US 2020/0123485 A1) (hereinafter referred to as Tamayol, see PTO-892).
Regarding claim 7, Luo teaches the bioreactor of claim 2.
Luo is silent to the bioreactor incorporated into a bioreactor system along with a housing that includes a self-contained power source for powering the drive system.
However, Wu in the art of culturing artificial tendons discloses a culture dish, i.e., a bioreactor, incorporated into a bioreactor, i.e., a bioreactor system, along with a box body, i.e., a housing (abstract).
Wu teaches that the box body allows the culturing environment to be controlled (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bioreactor of Luo to incorporate it into a bioreactor system along with a housing for the purpose of controlling the culturing environment, as taught by Wu.
The prior art combination is silent to a self-contained power source for powering the drive system.
However, Tamayol in the art of tissue engineering teaches it is known in the art to include a battery in a housing ([0049], “power supply 22 disposed within the housing”), i.e., a self-contained power source, for the purpose of powering a motor, i.e., powering a drive system ([0049], “power supply 22 includes one or more batteries”; ([0049]), “electrical actuator 24 may be…a direct current (DC) motor”; [0013], “flow of power from the power supply to the electrical actuator”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination bioreactor to include a self-contained power source for powering the drive system, as this method for improving the prior art combination was known in the art.
Regarding claim 8, the prior art combination teaches the bioreactor of claim 7.
Luo, as modified above, would have a motor included in the housing (Luo; Fig. 2, driving motor 13).
The limitation “configured to rotate the mechanical input of the drive system” is directed toward the intended manner of operating the claimed motor and does not differentiate the claimed motor from the prior art motor because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art motor would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 9, the claim as written is directed toward the intended manner of operating the claimed power source and the motor and does not differentiate the claimed power source and the motor from the prior art power source and the motor because all structural limitations are taught in the prior art (MPEP § 2114 II). The power source and motor taught by Tamayol and Luo respectively would be fully capable of achieving every claimed intended use because both the prior art power source and prior art motor can be controlled by a controller (Tamayol, [0050]; Luo, [0024]).
Regarding claim 10, the prior art combination teaches the bioreactor of claim 9, wherein the power source is a battery ([0049], “power supply 22 includes one or more batteries”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jiang et al. (US 2022/0169971 A1) discloses a cell training bioreactor for inducing tensile strain on tissues.
Lu et al. (US 2012/0100602 A1) discloses a system for mechanical stimulation of biological samples.
Subramanian et al. (US 2019/0093063 A1) discloses a scaffold-stretching system using a ball screw drive assembly.
Feeback et al. (US Patent 6,107,081 A) discloses a uni-directional cell stretching device.
Mayer et al. (WO 2010/129422 A1) discloses an multi-axial tension apparatus for engineering tissues.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADRIAN J CARREON whose telephone number is (571)272-6818. The examiner can normally be reached Monday - Friday 8:30 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 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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/A.J.C./Examiner, Art Unit 1799
/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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