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 .
Response to Amendment
Applicant’s amendment to the claims filed June 18, 2026 has been entered. Claim 1 is currently amended. Claims 1-18 are pending and under examination.
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 1-18 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 1, at lines 10-12, the claim recites “the lined channel within the fibre is able to act as a lumen for deployment of a medical device and/or is able to act as a microfluidic channel”. At lines 17-18, the claim recites “the lined channel of the surgical device fibre is configured to receive a medical device and/or is able to act as a microfluidic channel”. It is not clear how these different recitations are intended to be understood. While the recitations use different words to some extent, it is not clear how the different words have a different scope. It is not clear whether the second recitation is merely a repetition of the first or whether it provides an additional limitation not already required in the claim. Said differently, it is not clear how the scope of the claim is intended to be or would be different if lines 17 and 18 were not there. Appropriate correction and clarification are required. Claims 2-18 are rejected as dependent claims.
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.
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.
Claims 1-3, 7, 8, 11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 4,127,370) taken with or in view of Sato et al. (US 2008/0277810).
Regarding claim 1, Jackson teaches a method of manufacturing a polymer coated optical fiber using a draw apparatus (Abstract; Figure 1), the method comprising providing a preform/sleeve comprising a polymer and comprising a channel extending through the preform/sleeve to the draw apparatus (col. 1, lines 37-67; col. 2, lines 19-23; col. 8, line 52-col. 9, line 16); feeding an optical fiber into the channel of the preform/sleeve (col. 1, lines 37-67; col. 5, lines 37-42: heating a portion of the preform/sleeve (col. 2, lines 1-30; col. 6, lines 16-67); and drawing the heated portion of the preform/sleeve in order to form a fiber, wherein the optical fiber is held within the channel of the fiber/drawn sleeve/drawn preform, wherein prior to said drawing the cross section of the optical fiber is smaller than the channel's cross section; and wherein said drawing causes the preform/sleeve and the channel within it to narrow so that the optical fiber is held within the channel when the channel has narrowed (col. 1, lines 37-67; col. 2, lines 19-23; col. 7, line 48-col. 8, line 11; col. 8, lines 40-48).
Jackson does not teach the optical fiber is a liner comprising a thermoplastic or thermoset material (e.g. the optical fiber is not a hollow plastic optical fiber which would thereby be reasonably understood to be a “liner” as claimed).
However, Sato et al. teach an analogous method wherein the optical fiber is a hollow plastic (e.g. comprising one of a thermoplastic or thermoset material) optical fiber (Abstract; paragraphs [0002], [0010], [0015], [0016], [0038], [0065], [0178], Figure 1; Figure 15).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Jackson and Sato et al. and to have utilized a hollow plastic optical fiber/liner as claimed as the optical fiber to be coated with the sleeve/preform/outer fiber portion of Jackson, as suggested by Sato et al., for the purpose, as suggested by the references, of utilizing an optical fiber configuration known in the art to be effective for providing the desired functionality of an optical fiber for a variety of analogous applications and that provides lower transmission loss and low manufacturing cost (e.g. Sato et al. paragraphs [0002]).
In combination, the resulting product is a fiber comprising a lined channel as claimed (e.g. the outer polymeric sleeve is a fiber lined with a hollow plastic optical fiber which thereby products a fiber comprising a lined channel) and each and every limitation of the claimed invention is taught and reasonably suggested.
It is further noted that the combination of references works equally well in the opposite direction and the rejection is also considered to include the opposite rejection. In the opposite scenario, Sato et al. teach the formation of a hollow plastic optical fiber with a draw apparatus that is to then be coated with an outer polymer layer (paragraph [0038]). Sato et al. do not teach a necessary method of how to coat the polymer optical fiber with a polymer layer. That missing teaching is provided by Jackson as set forth above. The reason to combine the references is to effectively coat the optical fiber of Sato et al. by the method of Jackson in order to achieve the advantages associated with the coating technique of Jackson (e.g. col. 1, lines 33-35; col. 1, lines 55-58; col. 2, lines 1-22).
In the combination, in either direction, the formed fiber has dimensions that are suitable for incorporation into a surgical device and the lined channel is able (i.e. it is capable of and has the same/suitable structure) to act as a lumen for deployment of a medical device and/or is able to act as a microfluidic channel (the hollow configuration of the lined channel produced in the combination provides a structure that is intrinsically able to act as a lumen or as a microfluidic channel). The lined channel is also configured to/capable of receiving a medical device and/or it is able to act as a microfluidic channel. As such, it is a “surgical device fiber” to the extent required by the claim. (Sato et al. dimensions: paragraphs [0016], [0088], [0112], [0151], [0178]).
Although Jackson discloses a loosely held optical fiber which is arranged inside the sleeve to prevent buckling of the optical fiber, the optical fiber is still held within the channel of the sleeve to the extent required by the claim.
As to claims 2 and 3, in the combination, the axes are coaxial as claimed (Jackson Figures 1-4).
As to claims 7 and 8, Sato et al. teach the corresponding liner material comprises a fluoropolymer thermoplastic (paragraphs [0040]-[0046], [0080], [0083], [0104], [0151]). The reason to combine the references is the same as that set forth above.
As to claim 11, the optical fiber/liner has a circular cross section (Jackson Figures 1-4; Sato et al. Figure 15).
As to claim 17, in the combination, the heating of the polymeric sleeve/preform is at a temperature lower than the melting point of the optical fiber (e.g. glass fiber) (col. 7, line 48-col. 8, line 40).
Claims 4 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 4,127,370) taken with or in view of Sato et al. (US 2008/0277810), as applied to claims 1-3, 7, 8, 11, and 17 above, and further in view of Kim et al. (US 2012/0080225). Note: this is an alternative rejection of claims 7 and 8.
As to claim 4, the combination teaches the method set forth above. Jackson does not teach spaced apart axes as claimed. However, Kim et al. teach an analogous method, including spaced apart axes as claimed (Figures 2, 4 and 5). Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Jackson and Kim et al. and to have utilized spaced apart axes as claimed in the method of Jackson, as suggested by Kim et al., for the purpose, as suggested by Kim et al., of providing additional functionality and capacity to the fiber.
As to claims 7-9, the combination teaches the method set forth above. Jackson does not teach the optical fiber/liner is PTFE. However, Kim et al. teach an analogous method, including the use of PTFE as the optical fiber (paragraphs [0009], [0030], [0041], claims 3 and 20). Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Jackson and Kim et al. and to have utilized a PTFE material as claimed in the method of Jackson, as suggested by Kim et al., for the purpose, as suggested by Kim et al., of providing the functionality of the fiber with art recognized suitable and equivalent or alternative materials (see MPEP 2144.06 and 2144.07).
Claims 4-6, 12-14, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 4,127,370) taken with or in view of Sato et al. (US 2008/0277810), as applied to claims 1-3, 11, and 17 above, and further in view of Temelkuran et al. (WO 2020/174248).
As to claim 4-6, the combination teaches the method set forth above. Jackson does not teach spaced apart axes or a rotating step as claimed. However, Temelkuran et al. teach an analogous method (Abstract; Figure 1) wherein spaced about axes are disclosed (Figures 1, 4, 6-11) wherein the step of drawing further comprises rotating as claimed in the claimed manner to produce a helical channel as claimed (page 8, line 13 – page 9, line 11; page 10, line 21 – page 11, line 30; page 19, lines 9-34; pages 20, line 31-page 21, line 15).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Jackson and Temelkuran et al. and to have employed a preform and a liner with spaced apart axes as claimed in the manner as claimed, including a rotating step as claimed to produce a helical lined channel, in the method of Jackson, as suggested by Temelkuran et al., for the purpose, as suggested by the references, of producing a lined article suitable for use in a variety of applications (e.g. medical devices). In the combination, each and every limitation of claims 4-6 is taught and suggested.
As to claims 12-14, the combination teaches the method set forth above. Jackson does not teach utilizing a mandrel in the method as claimed. However, Temelkuran et al. provide analogous teaching wherein a polytetrafluoroethylene mandrel is utilized and then removed (pages 22, lines 33-page 23, line 5).
Therefore it would have been prima facie obvious to have combined the teaching of Jackson and Temelkuran et al. and to have utilized a mandrel as claimed in the method of Jackson, as suggested by Temelkuran et al., for the purpose, as suggested by Temelkuran et al., of preventing collapse of the preform/hollow/fiber, during processing. The combination reasonably suggests to the ordinarily skilled artisan the value of utilizing a mandrel during various processing steps, including during the drawing step as claimed, to prevent collapse during processing.
As to claim 16, the combination teaches the method set forth above. Jackson do not teach a preform with a plurality of channels with a plurality of liners as claimed produced as claimed. However, Temelkuran et al. teach an analogous method wherein preforms with multiple channels are employed and these channels can include additional preforms/liners (Figures 1, 4, 6-11; page 7, line 20-page 8, line 2; page 19, line 26-page 20, line 21).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Jackson and Temelkuran et al. and to have employed a preform having multiple channels and to have lined those multiple channels as claimed in the method of Jackson as suggested by Temelkuran et al., for the purpose as suggested by the references, of producing an article suitable for applications requiring more than one means of access therethrough. In the combination, each and every limitation of claim 16 is taught and suggested.
As to claim 18, Temelkuran et al. further teach that optical fibers can be utilized in a surgical device (Abstract; page 11, lines 23-34; page 12, line). It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Jackson and Temelkuran et al. and to have utilized the optical fiber of Jackson in a surgical device, as suggested by Temelkuran et al., for the purpose, as suggested by the references of utilizing optical fibers in art recognized suitable applications.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 4,127,370) taken with or in view of Sato et al. (US 2008/0277810), as applied to claims 1-3, 11, and 17 above, and further in view of Lee (US 2015/0025325).
As to claim 10, the combination teaches the method set forth above. Jackson does not teach the optical fiber/liner is a thermoset material. However, Lee teaches an analogous method, wherein a thermoset is utilized as the optical fiber (paragraph [0020]). Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Jackson and Lee and to have utilized a thermoset material as claimed in the method of Jackson, as suggested by Lee, for the purpose, as suggested by Lee, of providing the functionality of the fiber with art recognized suitable and equivalent or alternative materials (see MPEP 2144.06 and 2144.07).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 4,127,370) taken with or in view of Sato et al. (US 2008/0277810), as applied to claims 1-3, 11, and 17 above, alone or further in view of Wetzel et al. (US 2018/0087189).
As to claim 15, the combination teaches the method set forth above. Further, one having ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to have removed some of the optical fiber/liner from a distal end of the sleeve in order to expose an opposite end of the optical fiber outside of the sleeve or to facilitate clamping/bonding/molding the sleeve to a connection. Further, provide Wetzel et al. teach, in some embodiments, removing the inner material, from the rest of the drawn filament (paragraphs [0061] and [0093]). It would have been prima facie obvious to have combined the teaching of Jackson and Wetzel et al. and to have removed a portion of the liner of Jackson as suggested by Wetzel et al., for the purpose, as suggested by Wetzel of providing the full length of the sleeve with support during manufacture while providing a desired polymeric distal end section for the final configuration for subsequent use.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 4,127,370) taken with or in view of Sato et al. (US 2008/0277810), as applied to claims 1-3, 7, 8, 11 and 17, and further in view of Bayindir et al. (US 2009/0097805).
As to claim 18, the combination teaches the method set forth above. Jackson does not teach manufacturing a surgical device comprising the fiber. However, Bayindir et al. teach an analogous method wherein a surgical device is manufactured from an analogous fiber (paragraphs [0003], [0013], [0058], [0059], [0068], [0174], [0212]-[0214] and [0231]).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Jackson and Bayindir et al. and to have manufactured a surgical device comprising the fiber in the method of Jackson, as suggested by Bayindir, for the purpose, as suggested by Bayindir, of utilizing an optical fiber in an art recognized suitable and effective manner/application.
Response to Arguments
Applicant’s arguments filed June 18, 2026 have been fully considered, but they are not persuasive. Generally, the arguments appear to take issue with the fact that the relied upon prior art is directed to a method of making an “optical fiber” while the claimed invention is directed to a method of making “a surgical device fiber”. However, as set forth in the body of the rejection above and further described below, the “optical fiber” produced by the combination is understood to be “a surgical device fiber” to the extent required by the claim. The examiner suggests the arguments do not fully consider what it is that is required in the claim under a reasonable interpretation for the fiber produced by the method to be appropriately considered “a surgical device fiber”. What is it that make the “surgical device fiber” in the claim a surgical device fiber? The argument seems to suggest it is the term “surgical device fiber”. However, the examiner submits the claim makes clear that it is the dimensions and the capability of the produced fiber to be utilized in the claimed manner. As such, if the prior art performs the claimed method steps with the claimed materials and produces a fiber having the required dimensions and that is capable of being utilized in the claimed manner, it meets the claim. As further described below, the prior art rejection set forth above meets the requirements.
As an initial matter, the combination of references performs each and every manipulative step set forth in the claims and performs the same steps with the same claimed materials. This does not appear to be in dispute. Further, the claimed method is understood to produce “a surgical device fiber” based on the dimensions of the fiber produced (i.e. “the fiber formed has dimensions that are suitable for incorporation into a surgical device”) and based on whether “the lined channel within the fiber is able to act as a lumen for deployment of a medical device and/or is able to act as a microfluidic channel” or, as repeated later in the claim whether “the lined channel of the surgical device fiber is configured to receive a medical device and/or is able to act as a microfluidic channel”. As such, a fiber produced by the claimed method steps that has “dimensions that are suitable” as claimed and that is able/ capable/configured to receive a medical device or that is able to act as a microfluidic channel is a fiber that reads upon the claimed “surgical device fiber”.
The hollow optical fiber produced by the combination has “dimensions that are suitable” as required by the claim and the fiber is able/ capable/configured to receive a medical device or that is able to act as a microfluidic channel (e.g. a medical device could be fed into the hollow portion of the fiber or a fluid could be fed through the channel of the fiber). As such, the fiber taught and suggested by the combination set forth in the rejection of claim 1 is a fiber that reads upon the claimed “surgical device fiber”. Further, this also makes clear that the rejection is not impermissible as argued for making the fiber unsuitable for its intended purpose. The fiber produced in the combination, unchanged, reads upon the claim and is suitable as required.
In the combination, in either direction, the formed fiber has dimensions that are suitable for incorporation into a surgical device and the lined channel is able (i.e. it is capable of and has the same/suitable structure) to act as a lumen for deployment of a medical device and/or is able to act as a microfluidic channel (the hollow configuration of the lined channel produced in the combination provides a structure that is intrinsically able to act as a lumen or as a microfluidic channel). The lined channel is also configured to/capable of receiving a medical device and/or it is able to act as a microfluidic channel. For example, the dimensions set forth by Sato et al. at paragraphs [0016], [0088], [0112], [0151], [0178] read upon the disclosed dimensions set forth in paragraph [0114] of the published application and also overlap the dimensions set forth in paragraphs [0119] and [0120] of the published application. As such, it is a “surgical device fiber” to the extent required by the claim.
Further, as set forth in the rejection of claim 18, the fiber produced by the combination in the rejection of claim 1 is utilized to produce a surgical device. Although not required to meet the scope of claim 1 for the reasons set forth above, this further suggests it is not only a “surgical device fiber” to the extent required by claim 1 (i.e. it is a fiber that can be utilized in a surgical device), but it is a fiber used/usable in a surgical device. This also further makes clear that utilizing the “optical fiber” of the prior art in a surgical device does not make it unsuited for its intended purpose because the prior art discloses utilizing an “optical fiber’ in the production of a surgical device. Further still, it is noted that claim 18 does not provide further details regarding additional steps associated with forming the “surgical device”. It is broadly applicable. For example, the claim does not necessarily require inserting the medical device recited in claim 1 into the lumen to form the surgical device.
Further, applicant argues the additional secondary references fail to remedy the deficiencies of Jackson and Sato. This argument is not persuasive. For the reasons set forth above, Jackson and Sato aren’t deficient as argued. The additional secondary references are only relied upon as set forth in the body of the rejection above.
For each of these reasons, the rejection is understood to be proper and it is submitted the claims would need to be further amended to overcome the prima facie case of obviousness. For example, if supported by the original disclosure, potentially claiming an inner and outer diameter of the hollow portion of the fiber that is outside of the values/ranges reasonably suggested by the applied prior art could conceivably overcome the applied prior art (e.g. see the dimensions set forth and suggested by Sato et al. in paragraphs [0016], [0088], [0112], [0151], [0178] and compare them with the values suggested by paragraphs [0114], [0119] and [0120] of the published application). Such an amendment would likely require further search and/or consideration.
Further, the examiner notes his availability to discuss the application via telephonic interview.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeff Wollschlager whose telephone number is (571)272-8937. The examiner can normally be reached M-F 7:00-3:30.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christina Johnson can be reached at 571-272-1176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEFFREY M WOLLSCHLAGER/Primary Examiner, Art Unit 1742
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