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 .
Status of the Claims
Claims 18-38 are currently pending. Claim 38 is newly added. Claims 18, 23, and 25-26 are currently amended. Claims 27-37 are currently withdrawn. Claims 18-26 and 38 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 05/13/2026, with respect to the rejection(s) of claim(s) 18 as currently amended under 102 have been fully considered and are somewhat persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Schabbach modified by Schabbach Fig. 29.
The amendments to the claims have obviated all previous 112(b) rejections except in regards to claim 25. Please see 112(b) rejection of claim 25 below.
Applicant argues (Remarks pg. 15-16) that Schabbach and Schabbach Fig. 29 do not disclose “a single lens face being molded as part of the optical guiding means” because Schabbach states that the collimating optics may be implemented as “individual, discrete components distinct from an injection moulded light pipe chassis”. Although Schabbach Fig. 29 does not disclose the single lens face being molded as part of the optical guiding means, as described in the 103 rejection of claim 24, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the single lens face be molded as part of the optical guiding means, 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 V-B “Making Integral”). Although Applicant argues that the instant application “clearly describes this integrate structure” (Remarks pg. 15) and explains that “the molded lens face may reduce the complexity of the optical guiding device because fewer parts are required and because the optical guiding device can be produced together with the single lens face as one part by a molding process” (Remarks pg. 15). For support, Applicant points to “Figures 6-7 and their corresponding description” (Remarks pg. 15).
In looking through the instant specification (references made to the related PGPUB):
Description, [0042] states “Fig. 6 shows a module 50…The module 50 comprises light pipes 100, 100′, and a single lens face 26, 26′ is being moulded at the sensor-side surface of each light pipe 100, 100′. The module 50 may be integrally formed by moulding.”
Summary, [0006] states “The moulding of a signal lens face as part of the optical guiding means may reduce the complexity of the optical guiding means since fewer parts are required. Furthermore, the production of the optical guiding means may be made less complex since the optical guiding means can be produced together with the single lens face as one part by a moulding process. Furthermore, these features may reduce the sensitivity of the optical system to manufacturing tolerances, for example by maintaining a more consistent sensor signal level for different positions of the movable dosage programming component relative to the optical guiding means.”
However, the reduction in complexity (for both assembly and production) by requiring fewer parts and the reduction of sensitivity to manufacturing tolerances are inherent and obvious design choices which do not change the function or form of the overall design besides making two parts integral.
Claim Objections
Claim 25 is objected to because of the following informalities:
Claim 25 line 3-4 reads “a interior”. This should read “[[a]]an interior”.
Appropriate correction is required.
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 25 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 25 recites the limitation “the internal surface” 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 some other previously introduced surface, in which case the naming convention should be altered to clarify the relationship. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
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) 18, 22, 24-26, and 38 is/are rejected under 35 U.S.C. 103 as being obvious over Schabbach et al (WO 2019101962 A1; hereafter Schabbach) in view of Schabbach fig. 29. 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”), the drug delivery device comprising
(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 emitted radiation 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 a shape 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).
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Schabbach is silent to wherein the at least one light pipe comprises one or more of the following features: 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.
Schabbach Fig. 29b, directed to a similar embodiment, 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).
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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 to have the sensor-side surface form a single lens face of collimating optics, 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-B), which describes that making multiple pieces, held rigidly secured together, into a single unit is a matter of obvious engineering choice. 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, a benefit which would have been obvious to a PHOSITA as a simple design choice.
Regarding claim 22, Schabbach as modified 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 24, Schabbach as modified by Schabbach fig. 29b discloses the optical guiding device of claim 18, as described above, including wherein the single lens face (lens 1004a; see annotated fig. 29b above; 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”) being formed as collimating optics (pg. 25 ln. 30-35 collimating lens 1004a) has a domed collimating entry face (see annotated fig. 29b above) internal to the at least one light pipe (light pipe 1002, fig. 29b, note 103 rejection of claim 18 above makes integral the single lens face and the light pipe, thus the domed collimating entry face is internal to the light pipe), 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.).
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 of the emitted radiation from the internal surface (see 112b interpretation above) of the at least one light pipe,
parallelize the emitted radiation in a interior 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 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.).
Regarding claim 26, Schabbach as modified discloses the optical guiding device of claim 18, as described above. Schabbach further discloses wherein the at least one light pipe has a shape of a conical frustum (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”).
Regarding claim 38, Schabbach as modified discloses the optical guiding device of claim 18, as described above. Schabbach further discloses wherein the at least one light pipe (1002) further 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.”); or
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 (note that at least one of the alternative light pipe features is disclosed by Schabbach).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schabbach as modified and applied to claim 18 above, and further in view of Wagner et al (US 20170118551 A1; hereafter Wagner).
Regarding claim 19, Schabbach as modified discloses the optical guiding device of claim 18, as described above.
Schabbach as modified 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 as modified 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 as modified and 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 emitted radiation, or wherein all coatings are transparent for the emitted radiation 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 emitted radiation, or
wherein all coatings are transparent for the emitted 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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schabbach as modified and applied to claim 18 above, and further in view of Schabbach fig. 29d.
Regarding claim 19, Schabbach as modified by Schabbach fig. 29b discloses the optical guiding device of claim 18, as described above.
Schabbach as modified 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. 29d, directed to a similar embodiment as Schabbach and Schabbach fig. 29b, teaches 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wang et al (US 20110266939 A1) - fig. 2, [0022], light guide body 100 has a local roughened surface 108 on an indenting part 104
Edmond et al (US 20110310587 A1) - figs. 1a-1b, [0038], light guide/conversion tube 110 is assembled with dome 126 extending into the light guide
Choi (KR 20190079513 A) - fig. 2, [0026], light guide 10 has a curved lens surface 11 at the end of the light guide
Note similar arrangement shown in Li (WO 2016127145 A1) fig. 1 and Pearce (GB 2331143 A) fig. 1
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.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 07/23/2026
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