DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The amendment filed 17 November 2025 has been entered.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 42 is 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 42 is unclearly worded. Further, the “solid material” is not defined. It is unclear from what material the “solid material” is made. Further, the reference to the solid material (etc.) is variable and renders the claim indefinite. See MPEP 2173.05(b)(II).
Claim Rejections - 35 USC § 102
Claim(s) 24-33, 47, and 53 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Solomon et al. (US 5794487) (“Solomon”).
Claim 24: a sealable isolator chamber having a sterilizable interior and capable of maintaining an aseptic environment within the chamber (“clean room” with “ultra-clean vacuum environment” is capable of this; intended use);
a decontaminatable hermetically sealed articulated manipulating arm mounted within the isolator chamber to an interior surface of the isolator chamber (“Arm 24 includes a lower arm link 26, an upper arm link 28, and a hand or end effector 30.”), the articulated manipulating arm consisting of a single shell (single shell at least at 26 in FIG. 3);
the articulated manipulating arm seals the pharmaceutical handling apparatus to a leak rate of less than 1x10-2 per hour (“Any particulates generated inside the robot links cannot escape into the clean environment. " "In addition a seal is required to prevent particles from the motor or link components from exiting into the ultra-clean vacuum environment”; the written description implies zero per hour);
the manipulating arm is configured and disposed for aseptic handling of the pharmaceutical materials within the sealed isolator chamber when the manipulating arm is decontaminated and the interior of the chamber is sterilized (“clean room” with “ultra-clean vacuum environment” is capable of this; “Robots must be vacuum-compatible, and able to handle materials in vacuum and corrosive environments which are hostile to humans.”; “Magnetic liquid 18 is held in place by a powerful magnets 16, thereby sealing the gap while allowing rotation of shaft 7, protecting against incursion of corrosive materials, and preventing exit of particulate contaminants.”; “Any corrosive materials on the exterior of the robot cannot get into the robot's internal components. Also, when used in a vacuum, the internal components need not be vacuum-compatible because the fluid seals provide an atmospheric barrier.”; decontamination may use corrosive materials in which Solomon’s apparatus is capable of operating; intended use);
Claim 25: wherein the articulated arm seals the pharmaceutical handling apparatus to a leak rate equal to or less than 5x10-3 per hour (the written description implies zero per hour);
Claim 26: wherein the articulated arm seals the pharmaceutical handling apparatus to a leak rate less than 2.5x10-3 per hour (the written description implies zero per hour);
Claim 27: wherein the articulated arm seals the pharmaceutical handling apparatus to a leak rate less than or equal to 5x10-4 per hour (the written description implies zero per hour);
Claim 28: wherein the articulated arm is multi-axis and comprises a plurality of interconnected hermetically sealed arm segments and an end effector (“integral bearing and fluid seal”; “In this system each of the major dynamic arm joints, including the shoulder, elbow, and wrist, are joined by sealed bearings 76, 104, 130. The sealed bearings 76, 104, 130 are magnetic fluid sealed bearings, also known as ferro-fluid sealed bearings, or equivalent fluid rotation seals.”);
Claim 29: wherein the end effector is configured to dispense a pharmaceutical product (30 is capable of this; intended use);
Claim 30: wherein the end effector is configured to support a tray (30 is capable of this; intended use);
Claim 31: wherein at least one of the plurality of arm segments is joined to another of the plurality of arm segments by a hermetically sealed rotary elbow joint, the rotary elbow joint comprising a rotatable hub, an elbow housing, and a radial seal member for hermetically sealing the hub to the elbow housing (“integral bearing and fluid seal”; “In this system each of the major dynamic arm joints, including the shoulder, elbow, and wrist, are joined by sealed bearings 76, 104, 130. The sealed bearings 76, 104, 130 are magnetic fluid sealed bearings, also known as ferro-fluid sealed bearings, or equivalent fluid rotation seals.”);
Claim 32: wherein at least one of the plurality of arm segments has a seamless single shell design (26/28; alternatively, The method of forming the apparatus is not germane to the issue of patentability of the apparatus itself. Therefore, the seamless single shell process design limitations have not been given patentable weight.);
Claim 33: wherein all of the plurality of arm segments have a seamless single shell design (26/28; alternatively, The method of forming the apparatus is not germane to the issue of patentability of the apparatus itself. Therefore, the seamless single shell process design limitations have not been given patentable weight.);
Claim 47: wherein a plurality of edges of at least one arm segment are radiused to facilitate removal of liquids (since 92 has circular profile, portion of 26 at its base has a profile which has a radius);
Claim 53: wherein the sealed multi-axis articulated arm is an automatically controlled and reprogrammable articulated arm (“robot”).
Claim Rejections - 35 USC § 103
Claims 34 and 38-40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Solomon in view of Mori (Japanese Patent Publication 11-888). Solomon discloses all the limitations of the claims as discussed above; and
Claim 34: the articulated arm further comprises a shaft having a rotational axis;
the shaft passes through an opening in the sealable isolator chamber; and
the shaft is configured to rotate around the axis
Claim 38: at least one drive system (22) disposed at least in part within the articulated arm apparatus and sealed from the sterilizable interior of the isolator chamber, wherein the drive system is arranged and configured for driving and controlling the shaft and the articulated arm (column 3, line 53 to column 4, line 4);
Claim 39: wherein the at least one drive system is further configured and disposed for driving and controlling the end effector (column 3, lines 16-30);
Claim 40: wherein the articulated arm comprises a plurality of arm segments, and one of the plurality of arm segments is a terminal arm segment and another one of the plurality of arm segments is a first arm segment operably attached to the shaft and wherein the end effector is attached to the terminal arm segment (FIG._3).
Solomon does not directly show:
Claim 34: the shaft is configured to move linearly along the axis.
Mori shows a similar device having:
Claim 34: the shaft is configured to move linearly along the axis (para. [0019]);
with a reasonable expectation of success for the purpose of reliably improving the movement of the articulated arms and processing yield of the transferred materials within the sealable isolator chamber (para. [0035]-[0036]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify Solomon as taught by Mori and include Mori’s similar device having:
Claim 34: the shaft is configured to move linearly along the axis;
with a reasonable expectation of success for the purpose of reliably improving the movement of the articulated arms and processing yield of the transferred materials within the sealable isolator chamber.
Claims 43-45 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Solomon in view of Mori and Bonora et al. (US 6,634,851) (“Bonora”). Solomon discloses all the limitations of the claims as discussed above. Solomon does not directly show:
Claim 43: wherein the terminal arm segment is the one of the at least one arm segments that comprises a stainless steel outer shell;
Claim 44: wherein an upper surface of at least one of the plurality of arm segments is configured to inhibit pooling of a liquid on the articulated arm apparatus and to facilitate runoff of the liquid from the articulated arm apparatus;
Claim 45: wherein the upper surface has a profile to direct contaminants off the upper surface.
Bonora shows a similar device having:
Claim 43: wherein the terminal arm segment is the one of the at least one arm segments that comprises a stainless steel outer shell (column 14, lines 50-56 suggest this);
Claim 44: wherein an upper surface of at least one of the plurality of arm segments is configured to inhibit pooling of a liquid on the articulated arm apparatus and to facilitate runoff of the liquid from the articulated arm apparatus (11/12 of Mori facilitates at least removal of materials since it is flat);
Claim 45: wherein the upper surface has a profile to direct contaminants off the upper surface (11/12 of Mori facilitates at least removal of materials since it is flat);
for the purpose of reducing bowing or hysteresis effects of the at least one hermetically sealed arm segment during operation (column 15, lines 48-53). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify Solomon and Mori as taught by Bonora and include Bonora’s similar device having:
Claim 43: wherein the terminal arm segment is the one of the at least one arm segments that comprises a stainless steel outer shell;
Claim 44: wherein an upper surface of at least one of the plurality of arm segments is configured to inhibit pooling of a liquid on the articulated arm apparatus and to facilitate runoff of the liquid from the articulated arm apparatus;
Claim 45: wherein the upper surface has a profile to direct contaminants off the upper surface;
for the purpose of reducing bowing or hysteresis effects of the at least one hermetically sealed arm segment during operation.
Claims 35-37 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Solomon in view of Mori, Koike (US 2007/0166135), Hara (US 2004/0137384), and Nagano (US 5,797,168). Solomon discloses all the limitations of the claims as discussed above. Solomon does not directly show:
Claim 35: wherein outer surfaces of the shaft and arm segments are stainless steel;
Claim 36: wherein the stainless steel is electro-polished;
Claim 37: wherein the stainless steel is one of 304, 316 and 316L stainless steel.
Koike shows a similar device having:
Claim 35: wherein outer surfaces of the shaft and arm segments are stainless steel (paragraph [0079]);
with a reasonable expectation of success for the purpose of preventing heat convection from causing any possible degradation of the apparatus’ movement (paragraph [0079]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify Solomon as taught by Koike and include Koike’s similar device having:
Claim 35: wherein outer surfaces of the shaft and arm segments are stainless steel;
with a reasonable expectation of success for the purpose of preventing heat convection from causing any possible degradation of the apparatus’ movement.
Hara shows a similar device having:
Claim 36: wherein the stainless steel is electro-polished (paragraph [0054]);
with a reasonable expectation of success for the purpose of preventing any possible rusting from degrading the apparatus’ movement (paragraph [0054]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify Solomon as taught by Hara and include Hara’s similar device having:
Claim 36: wherein the stainless steel is electro-polished;
with a reasonable expectation of success for the purpose of preventing any possible rusting from degrading the apparatus’ movement.
Nagano shows a similar device having:
Claim 37: wherein the stainless steel is one of 304, 316 and 316L stainless steel (column 5, line 64 to column 6, line 4);
with a reasonable expectation of success for the purpose of providing a design choice among a finite number of design choices (column 5, line 64 to column 6, line 4). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify Solomon, Hara, and Koike as taught by Nagano and include Nagano’s similar device having:
Claim 37: wherein the stainless steel is one of 304, 316 and 316L stainless steel;
with a reasonable expectation of success for the purpose of providing a design choice among a finite number of design choices.
Claim 41 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Solomon in view of Mori and Ono (US 2014/0109712). Solomon discloses all the limitations of the claims as discussed above.
Solomon does not directly show:
Claim 41: wherein the arm segment operably attached to the shaft is shorter than at least one other of the plurality of arm segments.
Ono shows a similar device having:
Claim 41: wherein the arm segment operably attached to the shaft is shorter than at least one other of the plurality of arm segments (paragraph [0027]);
for the purpose of providing a swing diameter of the arms to a particular swing diameter (paragraph [0028]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify Solomon and Mori as taught by Ono and include Ono’s similar device having:
Claim 41: wherein the arm segment operably attached to the shaft is shorter than at least one other of the plurality of arm segments;
for the purpose of providing a swing diameter of the arms to a particular swing diameter.
Claim 46 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Solomon in view of Mori, Bonora, and Ono. Solomon discloses all the limitations of the claims as discussed above.
Solomon does not directly show:
Claim 46: wherein the profile comprises at least one section with a slope of at least one degree with respect to the horizontal.
Ono shows a similar device having:
Claim 46: wherein the profile comprises at least one section with a slope of at least one degree with respect to the horizontal (FIG. 1 at leader 130 and between leaders 141 and 143);
for the purpose of relaxing manufacturing restraints or tolerances. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify Solomon, Mori, and Bonora as taught by Ono and include Ono’s similar device having:
Claim 46: wherein the profile comprises at least one section with a slope of at least one degree with respect to the horizontal;
for the purpose of relaxing manufacturing restraints or tolerances.
Claims 54-55 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Solomon in view of Yoshida et al. (US 2004/0185521) (“Yoshida”). Solomon discloses all the limitations of the claims as discussed above.
Solomon does not directly show:
Claim 54: wherein the sealed multi-axis articulated manipulating arm is decontaminatable by a gaseous agent;
Claim 55: wherein the gaseous agent is one of hydrogen peroxide, formaldehyde, and chlorine dioxide.
Yoshida shows a similar device having:
Claim 54: wherein the sealed multi-axis articulated manipulating arm is decontaminatable by a gaseous agent;
Claim 55: wherein the gaseous agent is one of hydrogen peroxide, formaldehyde, and chlorine dioxide (para. [0161]);
with a reasonable expectation of success for the purpose of effectively sterilizing the sealable isolator chamber (para. [0161]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify Solomon as taught by Yoshida and include Yoshida’s similar device having:
Claim 54: wherein the sealed multi-axis articulated manipulating arm is decontaminatable by a gaseous agent;
Claim 55: wherein the gaseous agent is one of hydrogen peroxide, formaldehyde, and chlorine dioxide;
with a reasonable expectation of success for the purpose of effectively sterilizing the sealable isolator chamber.
Response to Arguments
Applicant's arguments filed 17 November 2025 have been fully considered but they are not persuasive.
Re. Claim 42, it is unclearly worded. Further, the “solid material” is not defined. It is unclear from what material the “solid material” is made. Further, the reference to the solid material (etc.) is variable and renders the claim indefinite. See MPEP 2173.05(b)(II).
In response to applicant's argument that Solomon, Bonora, and Mori are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Solomon, Bonora, and Mori are all reasonably in the field of the inventor’s endeavor, namely robotic handling.
Re. the single shell limitation, it is not in “paragraph [0036] of the instant specification”. It is in para. [0034] of the orig. spec. In the current application, there are fasteners 119, seals 300, and other structures connected to the single shell. Further, it is not claimed that other structures must be disconnected from the single shell (possible new matter if claimed). Solomon clearly has a single shell at least at 26 in FIG. 3. Claims limitations are read in light of the specification; the written description cannot further limit a claim limitation without the claim being further limited. MPEP § 2111 states, “The court explained that ‘reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.’ The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997) (The court held that the USPTO is not required, in the course of prosecution, to interpret claims in applications in the same manner as a court would interpret claims in an infringement suit. Rather, the ‘PTO applies to verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in applicant’s specification.’).”
Re. Mori, Mori is used for the movement of the shaft as claimed, not the sealing limitations which are found in Solomon. Mori was not used for the single shell limitation.
Re. Bonora and other applied prior art references, they were not used for the single shell limitation.
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 Gerald McClain whose telephone number is (571)272-7803. The examiner can normally be reached Monday through Friday from 8:30 a.m. to 5:00 p.m. and at gerald.mcclain@uspto.gov (see MPEP 502.03 (II)).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Saul Rodriguez can be reached at (571) 272-7097. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Gerald McClain/Primary Examiner, Art Unit 3652