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 in the reply filed on 07/14/2026 is acknowledged.
Claims 25-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/14/2026.
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.
Claims 16-24 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 16, the phrase “wherein at least one flag segment of the series of flag segments comprises one or more of a retention clip and a positioning pin” in lines 7-8 renders the claim indefinite because the examiner is unable to ascertain its scope. It is unclear if “one or more of a retention clip and a positioning pin” is intended to mean at least one flag segment comprises one or more retention clips and one or more positioning pins, one or more retention clips and a single positioning pin, or one or more of a pair comprising a retention clip and a positioning pin. From the PG PUB (US 20250127994) para. 0007-0008, examiner is interpreting this limitation as wherein at least one flag segment comprises a retention clip and/or a positioning pin.
Claim 18 recites the limitation "the distal end" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 17 and 19-24, these claims are indefinite due to their dependency upon a rejected base claim.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 16-18, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Schabbach et al. (W.O Patent Pub. No. 2019101962 A1, “Schabbach”) in view of Guala (U.S Patent Pub. No. 20130187381).
Regarding claim 16, Schabbach discloses the limitations of (Claim 16) an encoder ring (900 in Fig. 9-13) for a dose recording system of a drug delivery device (1, see p.3, lines 1-4), the encoder ring (900) comprising:
a support ring having a substantially circular configuration and comprising a proximal end face and a distal end face (see Fig. 9-10, p.11, lines 33- p.12, lines 1-2, and annotated Schabbach drawing 1 below – the reflective component shown as the lighter shaded region may be an injection molded polymer component or metal component that is separate from the non-reflective/absorbent component shown as the darker shaded region, the internal ring annotated below is interpreted as the support ring as it is circular and has a proximal end face shown in Fig. 10 and a distal end face opposite thereof); and
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a series of flag segments (70a in Fig. 9-10) rigidly connected to each other via the support ring (see p.11, lines 33-p.12, lines 1-2 and p.15, lines 10-13 – flag segments 70a are connected to one another via the annotated support ring above, being that the component may be formed from metal and is mounted to the dial sleeve 70 this indicates rigid connection), wherein each flag segment (70a) has a substantially rectangular outer surface extending in a curved plane (see Fig. 9).
However, Schabbach fails to disclose (Claim 16) wherein at least one flag segment of the series of flag segments comprises one or more of a retention clip and a positioning pin.
Guala discloses a medical connector (1 in Fig. 5), wherein the connector (1) comprises two injection molded parts (13 and 14 in Fig. 5) with a retention mechanism for fixing the two injection molded parts together (see para. 0031). One of ordinary skill in the art would have consulted the retention mechanism for two injection molded parts when solving the problem of a retention mechanism for the injection molded flag segments of an encoder ring. Guala teaches a first component (13 in Fig. 5) with a series of segments (15 in Fig. 5) each comprises a retention clip and a positioning pin for coupling the first component (13) to the second component (14, see para. 0031 – segments 15 comprise teeth 16 for snap-engagement with pawling parts 17 of the second component 14, wherein teeth 16 comprise a distally extending portion interpreted as the positioning pin as it fits within the recess of the second component 14 seen in Fig. 5 and a radially inwardly extending portion interpreted as the retention clip as it snap-fit around the pawling part 17).
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Since Schabbach discloses an encoder ring having two components each with a series of circumferentially disposed segments that are alternated with one another and that may be injection molded, and Guala discloses a connector having two injection molded components each with a series of circumferentially disposed segments that are alternated with one another, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flag segments (70a) of Schabbach to each have a retention clip an positioning pin as taught by Guala such that each flag segment (70a) of Schabbach would comprise a distally extending positioning pin and radially inwardly extending retention clip as taught by Guala. Guala provides that the snap-action engagement with the teeth (16) and pawling parts (17) of the first (13) and second components (14), respectively, ensures the two components are axially fitted and locked to one another (see para. 0011 and 0031).
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Regarding claim 17, modified Schabbach discloses the encoder ring of claim 16, as discussed above. In modified Schabbach, Schabbach discloses the limitations (Claim 17) the flag segments (70a) comprising a first and second flag segment that are non-adjacent with respect to each other (see annotated Schabbach drawing 2 below – first and second flag segments 70a have a non-reflective segment 70b therebetween making them non-adjacent).
In modified Schabbach, Guala discloses (Claim 17) wherein a first segment of the series of segments (15 in Fig.5) comprises a first retention clip protruding radially inwards from a first distal end of the first segment (see annotated Guala drawing 1 above – the retention clip is interpreted as the radially inwardly extending portion of teeth 16 that extends from the distal end of the segment 15), wherein a second segment of the series of segments (15) comprises a second retention clip protruding radially inwards from a second distal end of the second segment (see annotated Guala drawing 1 above), and wherein the first segment and the second segment are non- adjacent with respect to each other (see Fig. 4 and 5 – each segment 15 comprises the retention clip portion of the teeth 16, and a portion of second component 14 is between each segment 15 when they are coupled making segments 15 non-adjacent to one another).
Regarding claim 18, modified Schabbach discloses the encoder ring of claim 16 as discussed above. In modified Schabbach, Schabbach discloses the limitations of (Claim 18) four flag segments of the series of flag segments (70a in Fig. 9 – Schabbach discloses four flag segments 70a out of six flag segments 70a).
In modified Schabbach, Guala discloses (Claim 18) wherein each of four segments of the series of segments (15 in Fig. 5) comprises a positioning pin protruding distally from the distal end of a respective segment (see annotated Guala drawing 1 above and Fig. 5 – Guala discloses 4 segments 15 each having a positioning pin interpreted as the distally protruding portion of teeth 16 that extend from the segment’s distal end).
Regarding claim 21, modified Schabbach discloses the encoder ring of claim 16, as discussed above. In modified Schabbach, Schabbach discloses (Claim 21) wherein at least the substantially rectangular outer surface of each flag segment of the series of flag segments (70a in Fig. 9) has a surface reflecting IR light (see p.15, lines 10-18).
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Regarding claim 24, modified Schabbach discloses the encoder ring of claim 16, as discussed above. In modified Schabbach, Schabbach discloses (Claim 24) wherein one or more of the flag segments of the series of flag segments (70a in Fig. 9-10) have a dove tail shape in a cross section perpendicular to a central axis of the encoder ring (900, see annotated Schabbach drawing 3 below).
Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schabbach in view of Guala as applied to claim 16 above, and further in view of Takai (U.S Patent Pub. No. 20190137304 A1).
Regarding claim 19, modified Schabbach discloses the encoder ring of claim 16, as discussed above.
However, modified Schabbach fails to disclose (Claim 19) wherein the flag segments of the series of flag segments are equispaced over a circumference.
Takai discloses an optical rotation detecting device (1 in Fig. 1A-1D) comprising a ring (5b in Fig. 1D) having six light blocking parts (6 in Fig. 1B) and six light transmission parts (7 in Fig. 1B) that together function as a code disk of a rotary encoder (see para. 0025-0026). Takai teaches (Claim 19) wherein the segments (7) of the series of segments (7) are equispaced over a circumference (see Fig. 1D and para. 0026 – segments 6 and 7 are formed repetitively at regular intervals of 30 degrees around the circumference of ring 5b, being that there are 12 total segments extending over 30 degrees of the circumference to equal the full 360 degrees, the light transmissive segments 7 are thus equispaced over said circumference).
Since Schabbach discloses the encoder ring (900) comprises six flag segments (70a) alternated with six non-reflective segments (70b) around the circumference of the dial sleeve (70, see Fig. 10), and Takai discloses a similar encoder ring (5b) comprising six light transmissive segments (7) alternated with six blocking segments (6) around the circumference of the ring (5b), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flag segments of Schabbach to be equispaced over the circumference as taught by Takai according to known methods to yield predictable results. Since both Schabbach and Takai discloses a total of 12 segments in an optical encoder ring, one of ordinary skill in the art would have recognized that making each segment equispaced over the circumference of the encoder ring to thus extend 30 degrees of said circumference would have yielded results that were predictable.
Regarding claim 20, modified Schabbach discloses the encoder ring of claim 19, as discussed above. In modified Schabbach, Takai discloses (Claim 20) wherein each segment (7) of the series of segments (7) extends over 30º of the circumference (see Fig. 1D and para. 0026).
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Schabbach in view of Guala as applied to claim 21 above, and further in view of Nielsen et al. (U.S Patent Pub. No. 20080287865 A1, “Nielsen”).
Regarding claim 22, modified Schabbach discloses the encoder ring of claim 21, as discussed above.
While Schabbach discloses that the optical sensor system uses IR light (see p.15, lines 10-18), Schabbach fails to disclose (Claim 22) wherein the IR light comprises NIR light.
Nielsen discloses an optical sensor (2 in Fig. 1) configured for determining the positioning of a dose setting member (1 in Fig. 1) of an injection device comprising a light source for emitting light towards an optical coded path on the dose setting member (1) which has light reflective and light absorbing regions (see para. 0036 and 0038-0040), wherein the optical sensor (2) comprises one or more light sources capable of emitting light in the near infrared region (see para. 0048).
Since Schabbach discloses an optical sensor system for detecting the position of a dose setting member, and Nielsen discloses a similar optical sensor system for performing the same function, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the infrared light emitted and reflected by the flag segments of modified Schabbach to explicitly comprise NIR light as taught by Nielsen according to know methods to yield predictable results. Both Schabbach and Nielsen are optical sensors system that utilize light sources capable of emitting light towards optical coded patterns of segments for reflection and absorption. One of ordinary skill in the art would have recognized that using IR light in Schabbach specifically in the near-infrared region as taught by Nielsen would have yielded results that were predictable.
Claim(s) 23 is rejected under 35 U.S.C. 103 as being unpatentable over Schabbach in view of Guala as applied to claim 21 above, and further in view of Soni et al. (U.S Patent No. 6595427 B1, “Soni”).
Regarding claim 23, modified Schabbach discloses the encoder ring of claim 21, as discussed above. In modified Schabbach, Schabbach discloses the limitations (Claim 23) wherein at least the substantially rectangular outer surface of each flag segment of the series of flag segments (70a in Fig. 9) comprises a polymer material containing titanium oxide (see p.11, lines 33-36).
However, Schabbach fails to disclose that the polymer material containing titanium oxide is explicitly white.
Soni discloses a method of encoding information using in absorbing and reflecting radiation in infrared wavelengths (see Abstract), wherein Soni explicitly discloses titanium oxide being an example of a white pigment (see Col.8, lines 3-4).
Since Schabbach discloses using a polymer material containing titanium oxide on at least the outer surface of each flag segment, and Soni discloses that titanium oxide is an example of white pigment, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymer titanium oxide material of modified Schabbach to explicitly be white as taught by Soni. Soni discloses that optically encoded markings such as bar codes commonly use black and white pigments as the electrical signals produced by the detector from the black pigments are significantly different than those from the white pigments allowing the detector to determine the pattern (see Col.1, lines 24-37).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Weber (U.S Patent No. 6144027) - Weber discloses an optical angle sensor (1 in Fig. 1-3) for determining the steer angle in automative vehicles (see Abstract), wherein the angle sensor (1) comprises a support ring in the form of code disk (12 in Fig. 1-2) having spring struts (4 in Fig. 2-3) with locking hooks protruding radially inwards from the distal ends of each spring strut (4) for locking the code disk (12) onto the housing (1) in the axial direction (see Col.3, lines 9-26).
Bill et al. (U.S Patent Pub. No. 20200246548 A1, “Bill”) – Bill discloses an optical sensing system for detecting the rotary motion of the dosage sleeve (4 in Fig. 5) of an injection device (see Abstract), wherein the dosage sleeve (4 in Fig. 5) comprises a light-encoding device (106a in Fig. 5) on the radial outer periphery of said dosage sleeve (4) having a pattern of reflective material to reflect light from the light-transmitting device (103) to be detected by the light-receiving device (104, see para. 0062).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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