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
Claims 27-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions (Groups II-V), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/2025.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 01/05/2023, 08/07/2023, 06/24/2025, and 07/16/2025 have been considered by the Examiner.
Status of the Claims
Claims 18-37 are currently pending. Claims 18-26 are currently rejected. Claims 27-37 are currently withdrawn.
Specification
The amendment filed 02/09/2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of the international patent application PCT/EP2021/067443 and of the foreign patent application EP 20315325.9 is ineffective as it was added after the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 06/25/2021, see MPEP 1893.03(b). Therefore, the specification amendment of 02/09/2023 to include the incorporation by reference is new matter, per MPEP 608.01(p). Applicant is advised to remove the phrase “, the disclosures of which are incorporated herein by reference.” from the specification.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 18-26 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 18 recites the limitation “the radiation” on line 7. Claim 18 also recites the limitation "radiation" in line 5, in the phrase “by emitting radiation”, and “at least one reflection of the emitted radiation” on lines 5-6. It is unclear whether “the radiation” is meant to refer back to the emitted radiation, introduced on line 5 and referred as “the emitted radiation” on line 6, or whether “the radiation” on line 7 is meant to introduce a new, separate radiation. Please alter the naming convention to clarify, either by changing “the radiation” on line 7 to “the emitted radiation” or changing the terminology to better distinguish a new type of radiation. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 18 recites the limitation "the shape" in line 8. There is insufficient antecedent basis for this limitation in the claim. Either change “the shape” to “a shape” or consider a different re-wording such as changing “having the shape of a frustrum” to “having a shape of a frustrum”, “shaped like a frustrum”, “having a frustrum shape”, or similar. For the purposes of examination, this limitation has been interpreted to read “a shape”.
Claim 23 recites the limitation "the guided radiation" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation has been interpreted to refer back to either the emitted radiation or reflected radiation introduced in claim 18, or to introduce new, separate radiation which is guided. Please alter the naming convention to clarify this claim limitation.
Claim 25 recites the limitation “reflections from the internal surface” on line 2 and “reflections of the emitted radiation” on line 4. It is unclear whether one or both of these limitations refer back to the reflected radiation introduced in claim 18 or are meant to introduce new, separate reflections. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 25 recites the limitation “the internal surface” on line 2 and “the internal” on line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether the limitation “internal surface” is newly introducing a surface, in which case the instance on line 2 should read “an internal surface” or referring back to “a domed collimating entry face internal to the at least one light pipe” introduced in claim 24 upon which claim 25 depends. Furthermore, it is unclear whether the instance of “the internal” on line 3 of claim 25 is meant to refer back to the “internal surface”, in which case the instance of “the internal” on line 3 should be changed to “the internal surface”, or introduce a new limitation, in which case the naming convention should be altered to distinguish the new limitation. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 26 recites the limitation "the shape of a conical frustrum" in lines 1-2. It is unclear whether this refers back to the “shape of a frustrum” introduced in claim 18, further specifying that the frustrum is conical, or introduces a new frustrum, for a different light pipe, which is conical. Please clarify the claim language to better distinguish a new shape or clearly provide further specifics about the already introduced shape. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 19-26 are rejected at least for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the claims on which they depend.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 18, 22, and 26 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Schabbach et al (WO 2019101962 A1; hereafter Schabbach). Note that Schabbach was included in the IDS of 01/05/2023.
Regarding claim 18, Schabbach discloses an optical guiding device (module 1000, fig. 21) configured for application with a drug delivery device (injection device 1, fig. 1) (see fig. 21, note that the module 1000 is described in use with injection device 1; pg. 23 ln. 19-23, “Figure 21 shows essential parts of an embodiment of a module 1000 implementing this encoder concept: an indicator flag 1008 may be formed by relative rotation of a number sleeve 1006 around a rotation axis 1010, wherein the indicator flag 1008 is implemented in the shown embodiment by radially projecting teeth, formed in the top of for example the number sleeve or the dial sleeve 70 of the injection device 1”) that has
(i) a movable dosage programming component (number sleeve 1006, fig. 21, pg. 23 ln. 19-23) comprising a rotary encoder system (indicator flag 1008, fig. 21, pg. 23 ln. 19-23 “indicator flag 1008 may be formed by relative rotation of a number sleeve 1006 around a rotation axis 1010”) and
(ii) a sensor arrangement (optical sensor 215c and light pipe 1002, fig. 21 and fig. 23, pg. 23 ln. 23-24 “Figure 21 shows essential parts of a module 1000… an optical sensor 215c and collimating optics comprising two collimating lenses 1004a, 1004b and a light guidance in the form of a light pipe 1002”) comprising at least one optical sensor (optical sensor 215c), the at least one optical sensor configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to detect movement of the movable dosage programming component (number sleeve 1006) relative to the sensor arrangement (215c, 1002) during dosing of a drug (see pg. 26 ln. 25-27, module records doses delivered from the injection device) by emitting radiation and detecting at least one reflection of the emitted radiation from the rotary encoder system (pg. 23 ln. 28-30 “collimating optics comprising the lenses 1004a, 1004 and the light pipe 1002 are arranged between the active side, i.e. the IR emitting and receiving side of the optical sensor 215c and the indicator flag 1008 formed by the number sleeve 1006”; see fig. 23),
wherein the optical guiding device (module 1000, fig. 21) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to guide the radiation (see 112b interpretation above) and the at least one reflection of the emitted radiation (see incident and reflected rays in fig. 23 below which bounce through, and are guided through the light pipe 1002 of the optical guiding device 1000) and comprises at least one light pipe (light pipe 1002, fig. 21) having the shape (see 112b interpretation above) of a frustum (see fig. 21 and 23 which show that light pipe 1002 has the shape of a frustrum) with a sensor-side surface and an encoder-side surface (see fig. 21 and annotated fig. 23 below), and
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wherein the at least one light pipe (1002) comprises one or more of the following features:
a ratio of the sensor-side surface and the encoder-side surface being equal to or larger than about 1.0 (see fig. 21 and 23, note that since the light pipe 1002 is in the shape of a frustrum as shown and thus the ratio of the surface areas of the surfaces noted must be larger than 1.0; pg. 24 ln. 5-6 “The diameter of the light pipe reduces from the distal to the proximal end so that the light pipe 1002 has the shape of a frustum.”);
a ratio of a surface of a discreet encoding target of the rotary encoder system and the encoder-side surface being equal to or larger than 1.0;
the encoder-side surface having a roughness with an average feature size in a range of a wavelength of the radiation emitted by the at least one optical sensor; or
the sensor-side surface forms a single lens face being molded as part of the optical guiding device, wherein the single lens face is formed as collimating optics (note that at least one of the alternative light pipe features is disclosed by Schabbach).
Regarding claim 22, Schabbach discloses the optical guiding device of claim 18, as described above. Schabbach further discloses wherein a side wall of the at least one light pipe has a mirror finish (see fig. 23 above, internal side wall of light pipe 1002 reflects rays, thus acting as a mirror; pg. 24 ln. 1-14: “Figure 23 shows the light pipe 1002 and the guidance of radiation (represented by the dotted arrows) within the light pipe 1002.”).
Regarding claim 26, Schabbach discloses the optical guiding device of claim 18, as described above. Schabbach further discloses wherein the at least one light pipe has the shape of a conical frustum (see 112b interpretation above) (pg. 24 ln. 5-8: “The diameter of the light pipe reduces from the distal to the proximal end so that the light pipe 1002 has the shape of a frustum. Particularly, the light pipe 1002 may have a circular or an elliptic cross section”)
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schabbach as applied to claim 18 above, and further in view of Wagner et al (US 20170118551 A1; hereafter Wagner).
Regarding claim 19, Schabbach discloses the optical guiding device of claim 18, as described above.
Schabbach is silent to wherein the encoder-side surface comprises one or more of the following features: the encoder-side surface has a textured finish as surface finish; the encoder-side surface has a mirrored finish; the encoder-side surface comprises an antireflection coating; the encoder-side surface has an aspherical shaping; or the encoder-side surface has a spherical shaping.
Wagner, in the art of optical sensors using light pipes, teaches wherein the encoder-side surface (opposite distal end 40b, 42b; fig. 3a, [0104]) comprises one or more of the following features: the encoder-side surface has a textured finish as surface finish ([0108] In some embodiments, the end surface 40c, 42c of one or both of the light guides 40, 42 may be textured with a non-optically smooth finish such as an SPI (Society of Plastics Industry) B-1 finish, or the like. However, other finish texturing may be used in accordance with embodiments of the present invention including, but not limited to, SPI A-1, SPI A-2, SPI A-3, SPI B-2, and SPI B-3.); the encoder-side surface has a mirrored finish; the encoder-side surface comprises an antireflection coating; the encoder-side surface has an aspherical shaping; or the encoder-side surface has a spherical shaping.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the encoder-side surface of Schabbach to have a textured finish as taught by Wanger since both references deal with light pipes in sensor arrangements. One would have been motivated to make the modification by Wagner [0109] which notes “A textured surface can cause a “feathering” or “diffusing” of light from the optical source 24, thereby limiting the light that reflects directly from the tissue and into the optical detector 26. A diffuse optical beam may also be more uniform than a beam of light generated by the optical source 24. Diffused light beams may have an intensity distribution that is less sensitive to body motion and may be useful in alleviating motion artifacts in scattered light coming from the body and detected by the optical detector 26.”
Regarding claim 20, Schabbach modified by Wagner discloses the optical guiding device of claim 19, as described above, including wherein the textured finish (Wanger: [0108] end surface 40c is textured with a non-optically smooth finish) is a finish having a slight roughness or diffusivity (Wagner: [0109] A textured surface can cause a “feathering” or “diffusing” of light from the optical source 24, thereby limiting the light that reflects directly from the tissue and into the optical detector 26.).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schabbach modified by Wagner as applied to claim 19 above, and further in view of the SPI Surface Finish Standard Chart. Note that the chart is included below for reference, and a pdf of the SPI Surface Finish webpage, copyright 2008, is included as an NPL file with the Office Action.
Regarding claim 21, Schabbach modified by Wagner discloses the optical guiding device of claim 19, as described above, including wherein the textured finish is a finish according to a standard of the Society of Plastics Industry (SPI) (Wagner: [0108] In some embodiments, the end surface 40c, 42c of one or both of the light guides 40, 42 may be textured with a non-optically smooth finish such as an SPI (Society of Plastics Industry) B-1 finish, or the like. However, other finish texturing may be used in accordance with embodiments of the present invention including, but not limited to, SPI A-1, SPI A-2, SPI A-3, SPI B-2, and SPI B-3.).
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Schabbach as modified by Wagner teaches all limitations of the claim except wherein the textured finish is a finish according to the D3, D2 or D1 standard of the Society of Plastics Industry (SPI). It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use a textured finish according to the Society of Plastics Industry (SPI) other than those listed by Wagner ([0108] notes that “the finish texturing may be…including, but not limited to, SPI A-1, SPI A-2, SPI A-3, SPI B-2, and SPI B-3.”), since it has been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success involves only routine skill in the art. (See MPEP 2142(I)(E).) Since (1) Wanger [0109] notes the benefits of a textured finish for a light pipe; (2) Wagner suggests using a textured finish according to the Society of Plastics Industry (and noted in [0108] that possible finishes are not limited to those listed), and there are a finite number of SPI finishes (see SPI chart below from SPI Surface Finish); (3) one of ordinary skill in the art would have a reasonable expectation of success in view of Wagner [0108] noting the use of other SPI finishes for a light pipe end face; and (4) (A) both Schabbach and Wagner deal with light pipes, (B) the only difference between Schabbach modified by Wagner and the claim limitation is the difference in textured finish according to SPI, and (C) there are a limited number of SPI finishes, it would thus have been obvious to try all the SPI finishes and arrive at the claimed limitation for one of ordinary skill in the art.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schabbach in view of Ding et al (US 20150043242 A1; hereafter Ding).
Regarding claim 23, Schabbach discloses the optical guiding device of claim 18, as described above.
Schabbach is silent to wherein a side wall of the at least one light pipe comprises one or more coatings, wherein an outermost coating is non-transparent for the guided radiation (see 112b interpretation above), or wherein all coatings are transparent for the guided radiation (see 112b interpretation above) and an optical refractive index of each of the transparent coatings is smaller than an optical refractive index of the light pipe.
Ding, in the art of illuminating devices using light pipes, teaches wherein a side wall of the at least one light pipe comprises one or more coatings ([0057] circular truncated cone light pipe can be formed by plating a dichromic coating on two semicylindrical glass sheets through an existing coating process and using a method similar to the manufacturing method as shown in FIG. 9),
wherein an outermost coating is non-transparent for the guided radiation, or
wherein all coatings are transparent for the guided radiation and an optical refractive index of each of the transparent coatings is smaller than an optical refractive index of the light pipe (Note that Ding teaches at least one coating on a side wall of the light pipe, satisfying one of the alternatively claimed limitations.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Schabbach to include a dichromatic coating on a side wall of the light pipe as taught by Ding, since both references deal with channeling light through a light pipe. One would have been motivated to make the modification because, as noted in Ding [0057], a dichromic coating may selectively allow certain wavelengths of light to be transmitted while others are reflected, selecting so that the light pipe may channel only the wavelengths which are wanted for the intended purpose.
Claim(s) 19 and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schabbach as applied to claim 18 above, and further in view of Schabbach fig. 29.
Regarding claim 19, Schabbach discloses the optical guiding device of claim 18, as described above.
Schabbach is silent to wherein the encoder-side surface comprises one or more of the following features: the encoder-side surface has a textured finish as surface finish; the encoder-side surface has a mirrored finish; the encoder-side surface comprises an antireflection coating; the encoder-side surface has an aspherical shaping; or the encoder-side surface has a spherical shaping.
Schabbach fig. 29b, directed to a similar embodiment, wherein the encoder-side surface (see fig. 29d below, pg. 23 ln. 19-30, “collimating optics comprising two collimating lenses 1004a, 1004b and a light guidance in the form of a light pipe 1002”) comprises one or more of the following features: the encoder-side surface has a textured finish as surface finish; the encoder-side surface has a mirrored finish; the encoder-side surface comprises an antireflection coating; the encoder-side surface has an aspherical shaping (pg. 24 ln. 27-31, “the collimating lenses of the collimating optics should take the form of lenses featuring aspheric, or non-constant-curvature surfaces, which permit a collimating effect to be achieved in a smaller form factor optic”); or the encoder-side surface has a spherical shaping.
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the light pipe of Schabbach fig. 23 to include the collimating lens 1004a as shown in fig. 29d. One would have been motivated to make the modification by Schabbach pg. 24 ln. 31-pg. 25 ln. 4 which notes several benefits of employing collimating lenses including reducing “cross-talk” between neighboring sensors and improving detection of a binary state of the number sleeve target.
Regarding claim 24, Schabbach discloses the optical guiding device of claim 18, as described above.
Schabbach, as applied above, is silent to wherein the sensor-side surface forms a single lens face being molded as part of the optical guiding device, wherein the single lens face is formed as collimating optics (see claim 18, alternative features), and
wherein the single lens face being formed as collimating optics has a domed collimating entry face internal to the at least one light pipe, wherein the domed collimating entry face comprises a surface shape different in two orthogonal cross sectional planes.
Schabbach fig. 29b, directed to a similar arrangement of optical elements, teaches wherein the sensor-side surface forms a single lens face (lens 1004a; see annotated fig. 29b below; pg. 25 ln. 30-35, “Figure 29…(b), where a single collimating lens 1004a is provided, which covers both the transmitting and receiving portions of the optical sensor 215c”), wherein the single lens face (lens 1004a) is formed as collimating optics (pg. 25 ln. 30-35 collimating lens 1004a), and
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wherein the single lens face being formed as collimating optics (collimating lens 1004a) has a domed collimating entry face (see annotated fig. 29b above) to the at least one light pipe (light pipe 1002, fig. 29b), wherein the domed collimating entry face comprises a surface shape different in two orthogonal cross sectional planes (pg. 24 ln. 27-31, “the collimating optics should take the form of lenses featuring aspheric, or non-constant-curvature surfaces, which permit a collimating effect to be achieved in a smaller form factor optic, as exemplarily shown by the lens in picture (a) of Figure 24”). (Note that since the lens is aspheric, two different orthogonal cross sectional planes would not show the same surface shape.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the light pipe of Schabbach to have the sensor-side surface form a single lens face, as shown in Schabbach fig. 29b since both images are directed to similar embodiments. One would have been motivated to make the modification by Schabbach pg. 23 ln. 27-31 which notes that the aspheric lens allows “a collimating effect to be achieved in a smaller form factor optic” and Schabbach pg. 24 ln. 31-pg. 25 ln. 4 which notes several benefits of employing collimating lenses including reducing “cross-talk” between neighboring sensors and improving detection of a binary state of the number sleeve target.
Schabbach, modified by Schabbach fig. 29b, discloses the claimed invention except for the single lens face being molded as part of the optical guiding device, and the domed collimating entry face being internal to the at least one light pipe. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the collimating lens to be part of the light pipe, molded as a single part, which would thus make the entry face internal to the light pipe (since the lens would be part of the light pipe), since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. (See MPEP 2144.04 (V-C).). One would have been motivated to make the modification because combining the lens and the light pipe simplifies the chassis of Schabbach, since the chassis need not individually hold the lens separately from the light pipe, but only needs to hold the light pipe which includes the lens. This modification would thus remove the risk of misalignment of the collimating lens with the light pipe, improving device reliability.
Regarding claim 25, Schabbach modified by Schabbach fig. 29b discloses the optical guiding device of claim 24, wherein the surface shape of the domed collimating entry face is designed to
reduce reflections (see 112b interpretation above) from the internal surface (see 112b interpretation above) of the at least one light pipe,
parallelize radiation emitted in the internal (see 112b interpretation above) of the at least one light pipe (pg. 23 ln. 15-17, “The lens geometry may be selected to parallelize (“collimate”) divergent radiation emitted by the at least one optical sensor prior to transmission through the light pipe between the at least one sensor and the target, namely the indicator flag.”), and/or
to focus reflections of the emitted radiation (see 112b interpretation above) from the rotary encoder system (Note that Schabbach as modified satisfies at least one of the and/or limitations and thus satisfies the claim limitation.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 02/10/2026