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 .
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/13/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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 Objections
Applicant is advised that should claim 21 be found allowable, claim 65 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1-3, 5-11, 16, 18-19, 33-39, 42-48, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Sittampalam et al. (US Patent Application Publication 2013/0059324).
Regarding claim 1, Sittampalam et al. discloses a bioreactor (the device is configured to perform a controlled stimulation of cultured cells and thus reads on a bioreactor, see Abstract and para. 24-25) comprising:
a bioreactor chamber (one or more sample wells) (para. 37);
a membrane wall (114) disposed on the bioreactor chamber (para. 38), wherein the membrane wall has two or more surfaces which form an outer boundary of the bioreactor chamber (e.g., a first surface facing towards the chamber and a second surface facing away from the chamber, see Figs. 1B-2C, sheets 1-2 of 13), that form a seal with the bioreactor chamber (para. 38), wherein the bioreactor chamber and the membrane wall are configured to maintain sanitation within the bioreactor chamber while the bioreactor chamber is closed (the chamber and the membrane wall maintain a fluid tight seal, see para. 38, and thus sanitation is maintained as fluid contaminants cannot enter the chamber);
a scaffold structure disposed inside the bioreactor chamber (para. 118, 135);
a linear actuator disposed outside the bioreactor chamber (para. 53, 56) (Fig. 2B, sheet 2 of 13); and
a linear transfer means for transferring linear motion between the linear actuator and the scaffold structure without breaching the membrane wall (one or more pins 118; reads on the claimed linear transfer means, a term that invokes 112(f) and has been interpreted to cover an inner and outer coupling mechanism for transferring linear motion, and structural equivalents thereof for performing the claimed function, consistent with Applicant’s specification) (Abstract, para. 39-41).
Sittampalam et al. does not expressly teach a control system in communication with the linear actuator configured to control the movement of the linear actuator.
However, Sittampalam et al. discloses a control system for controlling the movement in general (para. 25) and discloses, in a related embodiment, a control system in communication with a hydraulic actuator configured to control the movement of the hydraulic actuator to actuate the one or more pins (118) to impart a force to the membrane wall (para. 62-65, 71) (Figs. 6-7, sheets 6-7 of 13) for the purpose of cell stimulation (Abstract).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the device disclosed by Sittampalam et al. to comprise a control system in communication with the linear actuator configured to control the movement of the linear actuator, as Sittampalam et al. discloses such a control system in communication with an actuator configured to control the movement of the actuator in a related embodiment, the major difference being the type of actuator, and the skilled artisan would have been motivated to control movement of the linear actuator in order to stimulate cultured cells in a predictable manner.
Regarding claim 2, Sittampalam et al. discloses wherein the bioreactor chamber and the membrane wall are sealed together (para. 38) and Sittampalam et al. is devoid of mention of the chamber or membrane being sealed or otherwise permanently coupled to the linear actuator, linear transfer means, or control system; thus, it is understood that the device necessarily operates such that the bioreactor chamber and membrane wall are configured to separate from the linear actuator, linear transfer means, and control system while maintaining the sanitation and without breaking the seal of the membrane wall. In any case, it has been held that making elements separable is a prima facie obvious modification (MPEP 2144.04), and it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to make the bioreactor chamber and membrane wall disclosed by Sittampalam et al. configured to separate from the linear actuator, linear transfer means, and control system to allow the bioreactor chamber and membrane wall to be moved to another location after processing, e.g., for further analysis and/or treatment of a sample within the bioreactor chamber. The sanitation and seal would necessarily be maintained as the membrane is sealed to the chamber alone, as discussed above.
Regarding claim 3, Sittampalam et al. discloses wherein the chamber is one or more wells of a conventional multiwell plate (para. 36, 118) and therefore the separated bioreactor chamber is fully capable of being for shipping, transporting, or transferring.
Regarding claim 5, Sittampalam et al. discloses wherein the membrane wall comprises polymer (para. 48).
Regarding claim 6, Sittampalam et al. discloses wherein the scaffold structure is configured to be able to move along a one directional axis (para. 40-41, 118, 135).
Regarding claim 7, Sittampalam et al. discloses wherein the scaffold structure comprises one or more cell seeding scaffolds (para. 118, 135).
Regarding claim 8, Sittampalam et al. discloses wherein the scaffold structure is double sided (para. 118, 135).
Regarding claim 9, Sittampalam et al. is silent as to wherein the scaffold structure is configured to be removable from the bioreactor chamber when the bioreactor chamber is in an open position.
Nonetheless, it has been held that making elements separable is a prima facie obvious modification (MPEP 2144.04), and it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to make the scaffold structure taught by Sittampalam et al. removable to allow for removal and additional analysis of biological samples supported by the scaffold structure.
Regarding claim 10, Sittampalam et al. is silent as to wherein the bioreactor chamber is configured to allow repeated insertion and removal of said scaffold structure when the bioreactor chamber is in an open position.
Nonetheless, it has been held that making elements separable is a prima facie obvious modification (MPEP 2144.04), and it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to make the scaffold structure and bioreactor chamber taught by Sittampalam et al. configured such that the scaffold structure can be repeatedly inserted and removed into the bioreactor chamber, in order to allow for insertion and removal of one or more biological samples for repeated stimulation and/or analysis.
Regarding claim 11, Sittampalam et al. discloses wherein the linear actuator is a stepper motor (para. 56).
Regarding claim 16, Sittampalam et al. discloses wherein the linear actuator is a solenoid (para. 63, 71).
Regarding claim 18, Sittampalam et al. discloses wherein the linear actuator is configured to be activated cyclically (para. 29).
Regarding claim 19, Sittampalam et al. discloses wherein the bioreactor chamber and the membrane wall are sealed together (para. 38) and Sittampalam et al. is devoid of mention of the chamber or membrane being sealed or otherwise permanently coupled to the linear actuator; thus, it is understood that the device necessarily operates such that the bioreactor chamber and membrane wall are configured to separate from the linear actuator. In any case, it has been held that making elements separable is a prima facie obvious modification (MPEP 2144.04), and it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to make the bioreactor chamber and membrane wall disclosed by Sittampalam et al. configured to separate from the linear actuator to allow the bioreactor chamber and membrane wall to be moved to another location after processing, e.g., for further analysis and/or treatment of a sample within the bioreactor chamber. The sanitation and seal would necessarily be maintained as the membrane is sealed to the chamber alone, as discussed above.
Regarding claim 33, Sittampalam et al. discloses wherein the bioreactor chamber is configured to be sealed in a fluid tight manner (reads on hermetically sealed) (para. 38).
Regarding claim 34, Sittampalam et al. discloses wherein the bioreactor chamber is configured to be sealed in a fluid tight manner (reads on aseptically sealed) (para. 38).
Regarding claim 35, Sittampalam et al. discloses wherein the bioreactor chamber has an inner portion (Figs. 1-2, sheets 1-2 of 13) and the reference is devoid of mention of the inner portion containing any exposed metal surfaces (see entire reference), thereby fulfilling the claimed subject matter.
Regarding claim 36, Sittampalam et al. discloses wherein the linear actuator is disposed outside of the bioreactor chamber, as set forth above, and does not permeate the bioreactor chamber (Fig. 2, sheet 2 of 13), and Sittampalam et al. further discloses wherein the control system is outside of the bioreactor chamber and does not permeate the bioreactor chamber (Fig. 7, sheet 7 of 13).
Regarding claim 37, Sittampalam et al. discloses one or more ports disposed on the bioreactor chamber (upper openings of the one or more wells read on one or more ports) (para. 37, 42) (Fig. 2, sheet 2 of 13).
Regarding claim 38, Sittampalam et al. discloses wherein the bioreactor chamber is configured to permit gas and/or nutrient exchange (each of the one or more wells is open when the lid is removed and structurally capable of exchanging gas and/or nutrients) (para. 37, 42) (Fig. 2, sheet 2 of 13).
Regarding claim 39, Sittampalam et al. discloses a removable lid assembly (130) (para. 42).
Regarding claim 42, Sittampalam et al. discloses wherein the membrane wall has sufficient flexibility whereby the membrane wall can be displaced resultant to the linear motion in a linear direction of 2 mm (falls within the claim range) (para. 71).
Regarding claim 43, Sittampalam et al. discloses wherein the membrane wall has sufficient flexibility whereby the membrane wall can be displaced resultant to the linear motion in a linear direction of 2 mm (falls within the claim range) (para. 71).
Regarding claim 44, Sittampalam et al. discloses wherein the membrane wall has sufficient flexibility in the linear direction so as to permit the linear actuator and the scaffold structure to travel with respect to one another, in response to the linear motion, causing the membrane wall to flex in an ample manner so as to allow said linear actuator and said scaffold structure to couple with one another (Abstract, para. 41, 71) (Fig. 2, sheet 2 of 13).
Regarding claim 45, Sittampalam et al. discloses wherein the membrane wall has sufficient elasticity in the linear direction so as to permit the linear actuator and the scaffold structure to travel with respect to one another, in response to the linear motion, causing the membrane wall to stretch in an ample manner so as to allow said linear actuator and said scaffold structure to couple with one another (Abstract, para. 41, 71) (Fig. 2, sheet 2 of 13).
Regarding claim 46, Sittampalam et al. discloses wherein the membrane wall has sufficient deformability in the linear direction so as to permit the linear actuator and the scaffold structure to travel with respect to one another, in response to the linear motion, causing the membrane wall to deform in an ample manner so as to allow said linear actuator and said scaffold structure to couple with one another (Abstract, para. 41, 71) (Fig. 2, sheet 2 of 13).
Regarding claim 47, Sittampalam et al. discloses wherein the membrane wall is configured to allow movement in the linear direction so as to permit the linear actuator and the scaffold structure to travel with respect to one another, in response to the linear motion, causing the membrane wall to move in an ample manner so as to allow said linear actuator and said scaffold structure to couple with one another (Abstract, para. 41, 71) (Fig. 2, sheet 2 of 13).
Regarding claim 48, Sittampalam et al. discloses wherein the scaffold structure comprises an adherent material for securing the scaffold structure in place (para. 118-119), thus fulfilling the limitation of the claimed securement means.
Regarding claim 50, Sittampalam et al. discloses wherein the bioreactor chamber includes an enclosure (para. 37) (Figs. 1-2, sheets 1-2 of 13).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Sittampalam et al. (US Patent Application Publication 2013/0059324) in view of Dennis et al. (US Patent 6,114,164) (already of record).
Regarding claim 12, Sittampalam et al. discloses the linear actuator, as set forth above, wherein the linear actuator transfers linear motion for the stimulation of a biological sample (Abstract, para. 53-56) and can comprise various mechanisms such as a stepper motor “or any other linear actuator” (para. 56).
Sittampalam et al. is silent as to wherein the linear actuator is a rack and pinion.
Dennis et al. discloses a system for applying a mechanical stimulation to a tissue sample in a culture environment (Abstract) comprising a rack and pinion actuator for transferring linear motion for the mechanical stimulation (col. 4 lines 29-49)
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the linear actuator disclosed by Sittampalam et al. to comprise a rack and pinion, based on the teachings of Dennis et al., as such a modification simple substitution of one known element for another to obtain predictable results (MPEP § 2143), in this case, substituting a rack and pinion for the linear actuator mechanism disclosed by Sittampalam et al.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sittampalam et al. (US Patent Application Publication 2013/0059324) in view of Vogel et al. (US Patent Application Publication 2023/0050194) (already of record).
Regarding claim 13, Sittampalam et al. discloses the linear actuator, as set forth above, wherein the linear actuator transfers linear motion for the stimulation of a biological sample (Abstract, para. 53-56) and can comprise various mechanisms such as a stepper motor “or any other linear actuator” (para. 56).
Sittampalam et al. is silent as to wherein the linear actuator is a piston.
Vogel et al. discloses a bioreactor (Abstract) configured to apply mechanical stimulation to a biological sample via linear motion transferred between a pneumatic piston actuator and a piston element (para. 24, 55).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the linear actuator disclosed by Sittampalam et al. to comprise a piston, based on the teachings of Vogel et al., as such a modification simple substitution of one known element for another to obtain predictable results (MPEP § 2143), in this case, substituting a piston for the linear actuator mechanism disclosed by Sittampalam et al.
Regarding claim 14, Sittampalam et al. in view of Vogel et al. teaches a pneumatic piston, as set forth above.
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sittampalam et al. (US Patent Application Publication 2013/0059324) in view of Li et al. (CN 110577895 A) (machine translation) (already of record).
Regarding claim 15, Sittampalam et al. discloses the linear actuator, as set forth above, wherein the linear actuator transfers linear motion for the stimulation of a biological sample (Abstract, para. 53-56) and can comprise various mechanisms such as a stepper motor “or any other linear actuator” (para. 56).
Sittampalam et al. is silent as to wherein the linear actuator is a crank and slider mechanism.
Li et al. discloses a cell culture device comprising a crank and slider mechanism actuator for transferring linear motion for the mechanical stimulation of a biological sample (p. 8 para. 2-3).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the linear actuator disclosed by Sittampalam et al. to comprise a crank and slider mechanism, based on the teachings of Li et al., as such a modification simple substitution of one known element for another to obtain predictable results (MPEP § 2143), in this case, substituting a crank and slider for the linear actuator mechanism disclosed by Sittampalam et al.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Sittampalam et al. (US Patent Application Publication 2013/0059324) in view of Botvinick et al. (US Patent Application Publication 2012/0272745) (already of record).
Regarding claim 17, Sittampalam et al. discloses the linear actuator, as set forth above, wherein the linear actuator transfers linear motion for the stimulation of a biological sample (Abstract, para. 53-56) and can comprise various mechanisms such as a stepper motor “or any other linear actuator” (para. 56).
Sittampalam et al. is silent as to wherein the linear actuator is a leadscrew mechanism
Botvinick et al. discloses an apparatus for applying a mechanical stimulation to a biological sample (Abstract, para. 40) comprising leadscrew actuator mechanism configured to impart mechanical stimulation to the sample (para. 41).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the linear actuator disclosed by Sittampalam et al. to comprise a leadscrew mechanism, based on the teachings of Botvinick et al., as such a modification simple substitution of one known element for another to obtain predictable results (MPEP § 2143), in this case, substituting a leadscrew mechanism for the linear actuator mechanism disclosed by Sittampalam et al.
Claims 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Sittampalam et al. (US Patent Application Publication 2013/0059324) in view of Zhong et al. (US Patent Application Publication 2010/0029000).
Regarding claim 40, Sittampalam et al. discloses the removable lid assembly, as set forth above.
Sittampalam et al. is silent as to wherein the removable lid assembly has one or more ports for the flow of gases and/or nutrients.
Zhong et al. discloses that it is desirable to provide cultured cells with fresh nutrients throughout culturing (para. 2-3). To this end, Zhong et al. discloses a lid for a multiwell plate wherein the lid comprises one or more ports for the flow of nutrients (para. 28, 31).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the lid assembly disclosed by Sittampalam et al. to comprise one or more ports for the flow of nutrients, based on the teachings of Zhong et al., in order to provide fresh nutrients for cultured cells.
Regarding claim 41 Sittampalam et al. discloses the removable lid assembly, as set forth above.
Sittampalam et al. is silent as to wherein the removable lid assembly is configured to permit gas and/or nutrient exchange.
Zhong et al. discloses that it is desirable to provide cultured cells with fresh nutrients throughout culturing (para. 2-3). To this end, Zhong et al. discloses a lid for a multiwell plate wherein the lid comprises one or more ports for nutrient exchange (para. 28, 31).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the lid assembly disclosed by Sittampalam et al. to comprise one or more ports for nutrient exchange, based on the teachings of Zhong et al., in order to provide fresh nutrients for cultured cells.
Allowable Subject Matter
Claims 20-32, 49, and 65-66 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. Please note the objection to claim 65 discussed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
Prosecution Insights