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 .
Claim Objections
Claims 16, 18, 21, 24-25, 29-30, 32 and 35 is/are objected to due to the following informalities:
In claim 16, line 9, should recite “wherein the receiving section adjoins the receiving space and comprises”, since the use of the term “adjoining” is incorrect because the claim has not previously established that the receiving section adjusted the receiving space.
In claim 25, line 1, “the projection of the engaging section” should be corrected to “the radially inward extending projection of the engaging section” for claim language consistency.
In claim 25, line 3, “the geometry of the receiving space” should be corrected to “a geometry of the receiving space” since this phrase was not previously introduced.
In claim 25, line 3, “the radial recess” should be corrected to “the radial recess of the device component” for claim language consistency.
In claim 29, line 2, the term “a” should be inserted before the phrase “proximal direction”.
In claim 30, line 7, should recite “wherein the receiving section adjoins the receiving space and comprises”, for same reasons as claim 16 above.
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(s) 17, 22, 31 and 35 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 requires the locking arm to be attached to the body between “the locking position and the unlocking position”. However, it is unclear how the location of the arm is between “the locking position and the unlocking position”, since “the locking position” and “the unlocking position” are not structures. Applicant is therefore suggested to amend claim 17 to overcome rejection.
Claim 22 recites “a second beveled section”, however claim 22 does not depend on claim 20 which introduces a “first beveled section”. It is unclear if claim 22 is intended to recite “first beveled section” instead of “second beveled section” or if claim 21 (which claim 22 depends on) should depend on claim 20 to establish proper antecedent basis. For the sake of Examination, it is interpreted that claim 22 depends on claim 21 and claim 21 depends on claim 20. Therefore, Applicant is suggested to amend claim 21 to depend on claim 20 to overcome rejection of claim 22.
Claim 31, requires the locking arm to be attached to the body between “the locking position and the unlocking position” and therefore suffers from the same issues as claim 17. Applicant is therefore suggested to amend claim 31 to overcome rejection.
Claim 35, line 2 recites “a radial recess”. Claim 35 depends on claim 30 and claim 30 already introduces “a radial recess of the device component” on the last line of the claim. It is unclear if the “radial recess” of line 2 of claim 35 is the same as or different from the recess of claim 30. For the sake of Examination it is being interpreted the “radial recess” of claim 35 as being same as the “radial recess” of claim 30. Applicant is therefore suggested to amend claim 35 to recite “the radial recess” to overcome rejection.
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.
Claim(s) 16, 17, 18, 19, 21, 24-27 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rau et al. (US 20200093981 A1).
Regarding claim 16, Rau discloses a workpiece carrier (assembly nest 1 in Fig. 14A) for holding a device component (sub assembly 2 in Fig. 14A) of a drug delivery device (a tubular sub assembly of a drug delivery device [0007]) in an automated production line (an assembly nest for transporting a tubular sub assembly of a drug delivery device on an automated production line [0007]), the workpiece carrier comprising:
a body (brackets 81 and base 82 is interpreted as body in Fig. 14A) extending in a longitudinal direction (z) (brackets 81 extending longitudinally in Fig. 14A), the body defining a receiving space (see receiving space in annotated Fig. 14B below) sized to receive at least a portion of the device component (receiving space receives part of component 4A in Fig. 14B), and
a locking mechanism (first locking member and second locking member in annotated Fig. 14A together is interpreted as locking mechanism) comprising a first locking member (one of the clamping arm 79, one of the mounting parts 83 and one of the clamp 80 in combination is interpreted as first locking member in Fig. 14A; see annotated Fig. 14A) movable relative to the body between a locking position (first locking member in locking position in Fig. 14B) and an unlocking position (first locking member in unlocking position in Fig. 14A),
wherein the first locking member comprises a receiving section (mounting part 83 of first locking member in Fig. 14A) and an engaging section (clamping arm 79 of first locking member in Fig. 14A) separated from the receiving section, and
wherein the receiving section adjoining the receiving space (mounting part 83 surrounds receiving space in annotated Fig. 14A) comprises an inside face (inner surface of fingers 87 of the receiving section 83 of first locking member in Fig. 15 is interpreted as inside face) with a first contact section (one of the fingers 87 in Fig. 15 is interpreted as first contact section of first locking mechanism) facing radially inwardly towards the receiving space (fingers 87 is interpreted facing radially inward) to make contact with the device component upon insertion of the device component into the receiving space along the longitudinal direction (z) (first contact section 87 of first locking mechanism is in contact with component 4B as device component is inserted) to thereby induce a movement of the first locking member into the locking position (first locking member moves to locking position in Fig. 14B as device component is inserted).
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Annotated Fig. 14A of Rau
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Annotated Fig. 14B of Rau
Regarding claim 17, Rau disclosed all limitations of claim 16, Rau further discloses wherein the first locking member comprises a locking arm (clamp 80 of first locking member is interpreted as locking arm) pivotally attached to the body between the locking position and the unlocking position (clamp 80 of first locking member is attached to one of the brackets 81 via engaging section 79 of first locking member in Fig. 14A).
Regarding claim 18, Rau disclosed all limitations of claim 16. Rau further discloses wherein the receiving section and the engaging section of the first locking member are located on opposite sides of a hinge axis (receiving section 83 and engaging section 79 located on opposite sides of hinge 84 in annotated Fig. 14A above; it is interpreted the hinge axis is at hinge 84) such that a radially outwardly directed movement of the receiving section inducible by insertion of the device component into the receiving space causes a radially inwardly directed movement of the engaging section (upon insertion of device component 2 in Fig. 14B, the receiving section 83 moves radially outward and engaging section 79 moves radially inward).
Regarding claim 19, Rau disclosed all limitations of claim 16. Rau further discloses wherein the first locking member extends in the longitudinal direction (z) (portion of first locking member extends longitudinally in Fig. 14A) and wherein the receiving section and the engaging section are separated along the longitudinal direction (z) (portion of receiving section 83 and engaging section 79 is separated along longitudinal direction in Fig. 14A).
Regarding claim 21, Rau disclosed all limitations of claim 16. Rau further discloses wherein the inside face comprises a second contact section (one of the fingers 87 of first locking mechanism in Fig 15 is interpreted as second contact section) facing radially inwardly towards the receiving space (finger 87 faces radially inward in Fig. 15) to make contact with the device component upon insertion into the receiving space (second contact section 87 of first locking mechanism is in contact with component 4B as device component is inserted).
Regarding claim 24, Rau in the embodiment of Fig. 14A disclosed all limitations of claim 16. Rau further discloses in the embodiment of Fig. 14A wherein the engaging section comprises a radially inwardly extending projection (clamp 80 in Fig. 14A) to engage with a radial recess of the device component (device component is not part of the claimed “workpiece carrier” and therefore clamp 80 of Fig. 14A is capable of engaging with a radial recess if one were present).
Regarding claim 25, the embodiment of Rau in Fig. 14A as modified by the embodiment of Rau in Fig. 3A disclosed all limitations of claim 24. Rau further discloses wherein the projection of the engaging section comprises a first edge section (one of the side faces of clamp 80) and a second edge section (one of the side faces of clamp 80) separated along a circumferential direction (it is interpreted from Fig. 14A the two faces are separated along a circumferential direction) with regard to the geometry of the receiving space (it is interpreted the edges are separated with regard to geometry of the receiving space since the clamp 80 fits within the receiving space), wherein the first edge section is configured to engage with a first side edge of the radial recess (first side edge is capable of engaging with radial recess if one were present; see further reasons in rejection of claim 24 above) and wherein the second edge section is configured to engage with a second side edge of the radial recess of the device component (second side edge is capable of engaging with radial recess if one were present; see further reasons in rejection of claim 24 above).
Regarding claim 26, the embodiment of Rau in Fig. 14A as modified by the embodiment of Rau in Fig. 3A disclosed all limitations of claim 25. Rau further discloses wherein the first edge section and the second edge section each comprise a first corner section (the top corner of one of the side faces in Fig. 14A projected inward) and a second corner section (the bottom corner of one of the side faces of Fig. 14A projected inward) radially and circumferentially offset from each other (it is interpreted the corners of two side faces are radially and circumferentially offset).
Regarding claim 27, Rau disclosed all limitations of claim 16. Rau further discloses wherein the locking mechanism comprises a second locking member (one of the receiving sections 83, one of the engaging sections 79 and one of the clamp 80 is interpreted as second locking member; see annotated Fig. 14A above) movable relative to the body between a locking position (second locking member in locking position in Fig.14B) and an unlocking position (second locking member in unlocking position in Fig.14A) , wherein the first locking member and the second locking member are located on opposite sides of the receiving space (first and second locking members are seen located on opposite side in annotated Fig. 14A).
Regarding claim 29, Rau disclosed all limitations of claim 16. Rau further discloses wherein a longitudinal proximal end of the engaging section (clamp 80 is located at the proximal end of arm 79 in Fig. 14A) comprises a protrusion (clamp 80 in Fig. 14A) extending obliquely in proximal direction (the back corners of clamp 80 is interpreted as extending obliquely in proximal direction; see annotated Fig. 14A above) and radially outwardly (the back corners of clamp 80 is interpreted as extending radially outwardly in annotated Fig. 14A above.)
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 20 and 22 is/are rejected under 35 U.S.C.103 as being unpatentable over Rau et al. (US 20200093981 A1).
Regarding claim 20, Rau disclosed all limitations of claim 16. However, Rau failed to explicitly disclose wherein the inside face of the receiving section comprises a first beveled section adjoining longitudinally into the first contact section.
However, Rau teaches in Fig. 14A a curved portion in the inner face of the receiving section 83 between the end 85 and the part of section 83 hinged to hinge 84.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify Rau to include wherein the inside face of the receiving section comprises a first beveled section adjoining longitudinally into the first contact section, since one of ordinary skill in the art interprets the curved portion of the inner face in receiving section 83 to perform same function as a beveled section would by disposing the end 85 at an angle and thereby making it easier for the device component to engage with the receiving section 83, and since it has been held that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929). See MPEP 2144.05.II.A. In the instant case, engaging section would not operate differently if the inner face has beveled section. Further, Applicant places no criticality on the first beveled section in claim 20.
Regarding claim 22, Rau disclosed all limitations of claim wherein the inside face of the receiving section comprises a second beveled section adjoining longitudinally into the first contact section and adjoining longitudinally into the second contact section.
However, as interpreted by one of ordinary skill in the art in claim 20, the curved portion of the inner face in receiving section 83 to perform same function as a beveled section would by disposing the end 85 at an angle and thereby making it easier for the device component to engage with the receiving section 83.
Furthermore, one of ordinary skill in the art recognizes the first beveled section is to be duplicated to form a second beveled section, since it has been held “that mere duplication of parts has no patentable significance unless a new and unexpected result is produced”. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04.VI.B. Further, Applicant places no criticality on incorporating multiple discharge beveled sections.
Claims 23 and 28 is/are rejected under 35 U.S.C.103 as being unpatentable over the embodiment of Rau et al. (US 20200093981 A1) in Fig. 14A-14B further in view of the embodiment of Rau in Fig. 16.
Regarding claim 23, Rau in the embodiment of Fig. 14A disclosed all limitations of claim 16. However, Rau in the embodiment of Fig. 14A failed to explicitly disclose wherein the first locking member is mechanically coupled with a spring element configured to keep the first locking member in the unlocking position.
However, Rau teaches, in the embodiment of Fig. 16, a spring 99 that is configured via the mount 92 to keep the locking mechanism 94 in an unlocked position [0182].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the embodiment of Rau in Fig.14A to include wherein the first locking member is mechanically coupled with a spring element configured to keep the first locking member in the unlocking position as taught by the embodiment of Rau in Fig. 16 since such a modification enables the first locking member of Rau to be biased in an unlocked position [0182].
Regarding claim 28, the embodiment of Rau in Fig. 14A disclosed all limitations of claim 16. However, Rau in the embodiment of Fig. 14A failed to explicitly disclose wherein a longitudinal proximal end of an inside face of the engaging section comprises a beveled edge.
However, Rau in the embodiment of Fig. 16 teaches a bevel on an inside face of the arm 94.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the embodiment of Rau in Fig.14A to include wherein wherein a longitudinal proximal end of an inside face of the engaging section comprises a beveled edge as taught by the embodiment of Rau in Fig. 16 since such a modification enables device of Rau to abut opposite sides of the tubular body of device component to locate the tubular body in a non-axial direction [0180].
Claims 30-33 and 35 is/are rejected under 35 U.S.C.103 as being unpatentable over the embodiment of Rau et al. (US 20200093981 A1) in Fig. 14A-14B further in view of the embodiment of Rau in Fig. 3A-3B.
Regarding claim 30, Rau in the embodiment of Fig. 14A discloses a method (modifications of methods [0200]) of holding a device component (sub assembly 2 in Fig. 14A) of a drug delivery device (a tubular sub assembly of a drug delivery device [0007]) in an automated production line by using a workpiece carrier (assembly nest 1 in Fig. 14A) comprising a body (brackets 81 and base 82 is interpreted as body in Fig. 14A) extending in a longitudinal direction (z) (brackets 81 extending longitudinally in Fig. 14A), the body defining a receiving space (see receiving space in annotated Fig. 14B above) sized to receive at least a portion of the device component (receiving space receives part of component 4A in Fig. 14B), and a locking mechanism (first locking member and second locking member in annotated Fig. 14A together is interpreted as locking mechanism) comprising a first locking member (one of the clamping arm 79, one of the clamp 80 and one of the mounting parts 83 in combination is interpreted as first locking member in Fig. 14A; see annotated Fig. 14A) movable relative to the body between a locking position (first locking member in locking position in Fig. 14B) and an unlocking position (first locking member in unlocking position in Fig. 14A), wherein the first locking member comprises a receiving section (mounting part 83 of first locking member in Fig. 14A) and an engaging section (clamping arm 79 of first locking member in Fig. 14A) separated from the receiving section (engaging section 79 is seen separate from receiving section 83 in Fig. 14A), and wherein the receiving section adjoining the receiving space (mounting part 83 surrounds receiving space in annotated Fig. 14A) comprises an inside face (inner surface of fingers 87 of the receiving section 83 of first locking member in Fig. 15 is interpreted as inside face) with a first contact section (one of the fingers 87 in Fig. 15 is interpreted as first contact section of first locking mechanism) facing radially inwardly towards the receiving space (fingers 87 is seen facing radially inward in annotated Fig. 14A) to make contact with the device component upon insertion of the device component into the receiving space along the longitudinal direction (z) (first contact section 87 of first locking mechanism is in contact with component 4B as device component is inserted), the method comprises the steps of:
inserting the device component in a longitudinal distal direction into the receiving space of the workpiece carrier (device component 2 is seen inserted into receiving space in Fig. 14A),
bringing an outside facing first portion of the device component (cap 4B in Fig. 14A) in engagement with the receiving section of the first locking member (cap 4B engages with receiving section 83 in Fig. 14A) and thereby
inducing a movement of the first locking member into the locking position (first locking member moves to locking position in Fig. 14B as device component is inserted)
establishing an engagement of the engaging section of the first locking member with the device component (engaging section 79 engages with device component in Fig. 14B) but fails to explicitly disclose the engaging section engage with a radial recess of the device component.
However, Rau in the embodiment of Fig. 3A teaches grooves 36 on the tubular body 4A of sub assembly 2 to engage with arms 29 [0141].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the embodiment of Rau in Fig.14A to include the engaging section engage with a radial recess of the device component as taught by the embodiment of Rau in Fig. 3A since such a modification enables the device of Rau to further constrain the device component to move in axial direction [0141].
Regarding claim 31, the embodiment of Rau in Fig. 14A as modified by the embodiment of Rau in Fig. 3A disclosed all limitations of claim 30. Rau further discloses wherein the first locking member comprises a locking arm (clamp 80 of first locking member is interpreted as locking arm) pivotally attached to the body between the locking position and the unlocking position (clamp 80 of first locking member is attached to one of the brackets 81 via engaging section 79 of first locking member in Fig. 14A).
Regarding claim 32, the embodiment of Rau in Fig. 14A as modified by the embodiment of Rau in Fig. 3A disclosed all limitations of claim 30. Rau further discloses wherein the receiving section and the engaging section of the first locking member are located on opposite sides of a hinge axis (receiving section 83 and engaging section 79 located on opposite sides of hinge 84 in annotated Fig. 14A above; it is interpreted the hinge axis is at hinge 84) such that a radially outwardly directed movement of the receiving section inducible by insertion of the device component into the receiving space causes a radially inwardly directed movement of the engaging section (upon insertion of device component 2 in Fig. 14B, the receiving section 83 moves radially outward and engaging section 79 moves radially inward).
Regarding claim 33, the embodiment of Rau in Fig. 14A as modified by the embodiment of Rau in Fig. 3A disclosed all limitations of claim 30. Rau further discloses wherein the first locking member extends in the longitudinal direction (z) (portion of first locking member extends longitudinally in Fig. 14A) and wherein the receiving section and the engaging section are separated along the longitudinal direction (z) (portion of receiving section 83 and engaging section 79 is separated along longitudinal direction in Fig. 14A).
Regarding claim 35, the embodiment of Rau in Fig. 14A as modified by the embodiment of Rau in Fig. 3A disclosed all limitations of claim 30. Rau further discloses in the embodiment of Fig. 14A wherein the engaging section comprises a radially inwardly extending projection (clamp 80 in Fig. 14A) to engage with the device component (clamp 80 is seen engaging with the device component 2 in Fig. 14A) but failed to explicitly disclose the radially inwardly extending projection engage with a radial recess of the device component.
However, Rau in the embodiment of Fig. 3A teaches grooves 36 on the tubular body 4A of sub assembly 2 to engage with arms 29 [0141].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the embodiment of Rau in Fig.14A to include the radially inwardly extending projection engage with a radial recess of the device component as taught by the embodiment of Rau in Fig. 3A since such a modification enables the device of Rau to further constrain the device component to move in axial direction [0141].
Claims 34 is/are rejected under 35 U.S.C.103 as being unpatentable over the embodiment of Rau et al. (US 20200093981 A1) in Fig. 14A-14B further in view of the embodiment of Rau in Fig. 3A-3B and the embodiment of Rau in Fig. 16.
Regarding claim 34, the embodiment of Rau in Fig. 14A as modified by the embodiment of Rau in Fig. 3A disclosed all limitations of claim 30. However, Rau in the embodiment of Fig. 14A as modified by the embodiment of Fig. 3A failed to explicitly disclose wherein the first locking member is mechanically coupled with a spring element configured to keep the first locking member in the unlocking position.
However, Rau teaches in the embodiment of Fig. 16 the spring 99 that is configured via the mount 92 to keep the locking mechanism 94 in an unlocked position [0182].
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the embodiment of Rau in Fig.14A as modified by the embodiment of Fig.3A to include wherein the first locking member is mechanically coupled with a spring element configured to keep the first locking member in the unlocking position as taught by the embodiment of Rau in Fig. 16 since such a modification enables the first locking member of Rau to be biased in an unlocked position [0182].
Conclusion
The prior art of record and not relied upon is considered pertinent to applicant’s disclosure:
Josef (US 10328198 B2) drawn to workpiece carrier for drug delivery device.
Carpenter (US 20200155768 A1) drawn to supporting device for a drug delivery device.
Carpenter (US 20210268171 A1) drawn to supporting arrangement for a drug delivery device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday-Friday: 7:30-5:00p EST. 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.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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