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 .
Specification
The abstract of the disclosure is objected to because:
In line 5, “an intravenous catheter assembly” should be changed to “the intravenous catheter assembly”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 3, 5-7, 9-10, 12, and 14-19 are objected to because of the following informalities:
In regards to claim 1, line 7, “an intravenous catheter assembly” should be changed to “the intravenous catheter assembly”.
In regards to claim 3, line 2, “light” should be changed to “the light”.
In regards to claim 5, line 1, “LEDS” should be changed to “LEDs”.
In regards to claim 6, line 3, “the inner surface” should be changed to “an inner surface”.
In regards to claim 7, line 5, “LEDS” should be changed to “LEDs”.
In regards to claim 7, line 6, “LEDS” should be changed to “LEDs”.
In regards to claim 9, line 1, “LEDS” should be changed to “LEDs”.
In regards to claim 10, line 8, “power” should be changed to “the power”.
In regards to claim 10, line 8, “light” should be changed to “the light”.
In regards to claim 12, line 3, “light” should be changed to “the light”.
In regards to claim 14, line 13, “an access connector” should be changed to “the access connector”.
In regards to claim 14, line 13, “an intravenous catheter assembly” should be changed to “the intravenous catheter assembly”.
In regards to claim 15, line 5, “light” should be changed to “the light”.
In regards to claim 16, line 2, “LEDS” should be changed to “LEDs”.
In regards to claim 17, line 1, “LEDS” should be changed to “LEDs”.
In regards to claim 18, line 8, “power” should be changed to “the power”.
In regards to claim 18, line 8, “light” should be changed to “the light”.
In regards to claim 19, line 3, “light” should be changed to “the light”.
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.
Claims 3, 6, 8, and 17 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.
In regards to claim 3, line 2 recites “the light source”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 3 depends upon claim 2. Claim 2, line 2 recites “a lighting element”. Claim 2 depends upon claim 1. Claim 1, line 11 recites “a light generating element”. It is unclear whether “the light source” of claim 3 is the same as or different from “a light generating element” of claim 1 or “a lighting element” of claim 2.
In regards to claim 6, line 2 recites “a plurality of LEDs”. Claim 6 depends upon claim 4. Claim 4, line 2 recites “one or more light emitting diodes (LEDs)”. It is unclear whether the two recitations are the same or different.
In regards to claim 8, line 2 recites “the LED”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 8 depends upon claim 7, which depends upon claim 4. Claim 4, line 2 recites “one or more light emitting diodes (LEDs)”. It is unclear whether the two recitations are the same or different.
In regards to claim 17, lines 2-3 recite “the instrument advancement device”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 17 depends upon claim 16, which depends upon claim 14. Claim 14, line 7 recites “an instrument delivery device” and line 14 recites “an advancement member”. It is unclear whether “the instrument advancement device” of claim 17 is the same as or different from “an instrument delivery device” or “an advancement member” of claim 14.
Claim Rejections - 35 USC § 102
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.
Claims 1-3 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Isaacson et al (US 2017/0274156).
In regards to claim 1, Isaacson et al teaches an instrument delivery device (Figures 5A-5B) for use with an intravenous catheter assembly, the instrument delivery device comprising:
a housing (50) having a proximal end portion and a distal end portion, the housing defining an inner volume (Figures 5A-5B)
an instrument (10) movably received within the inner volume
a coupling device (40) positioned at the distal end portion of the housing and configured to couple the housing to an access connector of an intravenous catheter assembly (Figure 5A)
an advancement member (44) configured to move relative to the housing to advance a distal end of the instrument beyond the distal end portion of the housing and into the intravenous catheter assembly (Figure 5A)
a light generating element (18/22/35) disposed at least partially within the housing and configured to generate light that enables visualization of the instrument (paragraph [0031]: one or more of the optical fibers 18 may be configured to emit light)
In regards to claim 2, Isaacson et al teaches wherein the light generating element comprises a lighting element (18/22/35) positioned adjacent the distal end portion or the proximal end portion of the housing.
In regards to claim 3, Isaacson et al teaches an optical fiber (18) extending out from the light source (35) and configured to transmit light along a length of the optical fiber (paragraph [0043]).
In regards to claim 14, Isaacson et al teaches a catheter system (Figures 5A-5B), comprising:
an intravenous catheter assembly (Figures 5A-5B) comprising:
a catheter (38) comprising a distal end and a proximal end, the catheter defining a lumen extending between the distal end and the proximal end (Figure 5A)
an access connector (36) configured to provide access to the lumen of the catheter (Figure 5A)
an instrument delivery device (Figures 5A-5B) coupleable to the access connector, the instrument delivery device comprising:
a housing (50) having a proximal end portion and a distal end portion, the housing defining an inner volume (Figures 5A-5B)
an instrument (10) movably received within the inner volume
a coupling device (40) positioned at the distal end portion of the housing and configured to couple the housing to an access connector of an intravenous catheter assembly (Figure 5A)
an advancement member (44) configured to move relative to the housing to advance a distal end of the instrument beyond the distal end portion of the housing and into the intravenous catheter assembly (Figure 5A)
a light generating element (18/22/35) disposed at least partially within the housing and configured to generate light that enables visualization of the instrument (paragraph [0031]: one or more of the optical fibers 18 may be configured to emit light)
In regards to claim 15, Isaacson et al teaches wherein the light generating element comprises:
a lighting element (18/22/35) positioned adjacent the proximal end portion of the housing
an optical fiber (18) extending out from the lighting element and configured to transmit light along a length of the optical fiber (paragraph [0043])
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4-6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al, as applied to claims 1 and 14 above, and further in view of Nebbia et al (WO 2019/123387).
In regards to claim 4, Isaacson et al does not teach wherein the light generating element comprises one or more light emitting diodes (LEDs), as Isaacson et al instead teaches wherein the light generating element comprises one or more optical fibers 18, a sheath 22, and a light emitter 35. Nebbia et al teaches a device (Figures 1-12) wherein a light generating element comprises one or more light emitting diodes (14). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the light generating element, of the device of Isaacson et al, to comprise one or more light emitting diodes, as taught by Nebbia et al, as such will allow for illuminating appropriately the biological tissues lying within the operating field, such as the surface capillaries and the details of the epithelial crests, the structure of the deeper mucosa, the ureters and the oesophagus, and the differences of fluorescence are used to distinguish healthy tissue from dysplastic tissue (page 7, lines 32-35, to page 8, lines 1-15).
In regards to claim 5, in the modified device of Isaacson et al and Nebbia et al, Isaacson et al does not teach wherein the one or more LEDS are affixed to an inner surface of the housing. Nebbia et al teaches wherein the one or more LEDS are affixed to an inner surface of a housing (11) (Figure 3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more LEDS, of the modified device of Isaacson et al and Nebbia et al, to be affixed to an inner surface of the housing, as taught by Nebbia et al, as such will allow for illuminating appropriately the biological tissues lying within the operating field, such as the surface capillaries and the details of the epithelial crests, the structure of the deeper mucosa, the ureters and the oesophagus, and the differences of fluorescence are used to distinguish healthy tissue from dysplastic tissue (page 7, lines 32-35, to page 8, lines 1-15).
In regards to claim 6, in the modified device of Isaacson et al and Nebbia et al, Isaacson et al does not teach wherein the light generating element comprises a light strip including a plurality of LEDs arranged on a substrate, the light strip affixed to the inner surface of the housing. Nebbia et al teaches wherein the light generating element comprises a light strip including a plurality of LEDs (14) arranged on a substrate (15), the light strip affixed to an inner surface of a housing (11). (Figure 3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the light generating element, of the modified device of Isaacson et al and Nebbia et al, to comprise a light strip including a plurality of LEDs arranged on a substrate, the light strip affixed to the inner surface of the housing, as taught by Nebbia et al, as such will allow for illuminating appropriately the biological tissues lying within the operating field, such as the surface capillaries and the details of the epithelial crests, the structure of the deeper mucosa, the ureters and the oesophagus, and the differences of fluorescence are used to distinguish healthy tissue from dysplastic tissue (page 7, lines 32-35, to page 8, lines 1-15).
In regards to claim 16, Isaacson et al does not teach wherein the light generating element comprises one or more light emitting diodes (LEDs), with the one or more LEDS affixed to an inner surface of the housing or to a portion of the advancement member positioned within the inner volume of the housing, as Isaacson et al instead teaches wherein the light generating element comprises one or more optical fibers 18, a sheath 22, and a light emitter 35. Nebbia et al teaches a system (Figures 1-12) wherein a light generating element comprises one or more light emitting diodes (14), with the one or more LEDS affixed to an inner surface of a housing (11) (Figure 3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the light generating element, of the system of Isaacson et al, to comprise one or more light emitting diodes, with the one or more LEDS affixed to an inner surface of the housing, as taught by Nebbia et al, as such will allow for illuminating appropriately the biological tissues lying within the operating field, such as the surface capillaries and the details of the epithelial crests, the structure of the deeper mucosa, the ureters and the oesophagus, and the differences of fluorescence are used to distinguish healthy tissue from dysplastic tissue (page 7, lines 32-35, to page 8, lines 1-15).
Claims 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al and Nebbia et al, as applied to claims 4 and 16 above, and further in view of Chen et al (CN 210130807).
In regards to claim 9, in the modified device of Isaacson et al and Nebbia et al, Isaacson et al does not teach wherein the one or more LEDS comprise micro-LEDs having dimensions of 1.5 mm×1.5 mm or less. And Nebbia et al does not teach wherein the one or more LEDS comprise micro-LEDs having dimensions of 1.5 mm×1.5 mm or less. Chen et al teaches a device (Figure 1) wherein one or more LEDS comprise micro-LEDs (6). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more LEDS, of the modified device of Isaacson et al and Nebbia et al, to comprise micro-LEDs, as taught by Chen et al, as such will allow for observing the anus of the patient for treating the anorectal lesion of the patient, and is convenient to carry in an ideal portable traditional Chinese medicine therapy apparatus for anus and intestine (Abstract).
However, Chen et al is silent about the micro-LEDs having dimensions of 1.5 mm×1.5 mm or less. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the micro-LEDs, of the modified device of Isaacson et al, Nebbia et al, and Chen et al, to have dimensions of 1.5 mm×1.5 mm or less, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified device of Isaacson et al, Nebbia et al, and Chen et al would not operate differently with the claimed dimensions of the micro-LEDs. Further, it appears that Applicant places no criticality on the range claimed for the dimensions of the micro-LEDs.
In regards to claim 17, in the modified system of Isaacson et al and Nebbia et al, Isaacson et al does not teach wherein the one or more LEDS comprise micro-LEDs having dimensions of 1.5 mm×1.5 mm or less, and wherein the instrument advancement device further comprises a battery to power the micro-LEDs. And Nebbia et al does not teach wherein the one or more LEDS comprise micro-LEDs having dimensions of 1.5 mm×1.5 mm or less, and wherein the instrument advancement device further comprises a battery to power the micro-LEDs. Chen et al teaches a system (Figure 1) wherein one or more LEDS comprise micro-LEDs (6), and wherein a device further comprises a battery (9) to power the micro-LEDs. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the one or more LEDS, of the modified system of Isaacson et al and Nebbia et al, to comprise micro-LEDs, and wherein the device further comprises a battery to power the micro-LEDs, as taught by Chen et al, as such will allow for observing the anus of the patient for treating the anorectal lesion of the patient, and is convenient to carry in an ideal portable traditional Chinese medicine therapy apparatus for anus and intestine (Abstract).
However, Chen et al is silent about the micro-LEDs having dimensions of 1.5 mm×1.5 mm or less. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the micro-LEDs, of the modified system of Isaacson et al, Nebbia et al, and Chen et al, to have dimensions of 1.5 mm×1.5 mm or less, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified system of Isaacson et al, Nebbia et al, and Chen et al would not operate differently with the claimed dimensions of the micro-LEDs. Further, it appears that Applicant places no criticality on the range claimed for the dimensions of the micro-LEDs.
Claims 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al, as applied to claims 1 and 14 above, and further in view of Pruitt et al (US 2004/0236275).
In regards to claim 12, Isaacson et al does not teach wherein the light generating element comprises a luminescent coating applied on at least a portion of the instrument, the luminescent coating generating light after exposure to ambient light, as Isaacson et al instead teaches wherein the light generating element comprises one or more optical fibers 18, a sheath 22, and a light emitter 35. Pruitt et al teaches a device (Figures 1-4) wherein a light generating element comprises a luminescent coating (a coating of the light emitting substance 32) applied on at least a portion of an instrument (10), the luminescent coating generating light after exposure to ambient light (paragraph [0025]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the light generating element, of the device of Isaacson et al, to comprise a luminescent coating applied on at least a portion of the instrument, as taught by Pruitt et al, as such will emit visible light, to facilitate the ability to see the instrument as other devices or components are introduced into or attached onto a port outlined by the luminescent coating during a medical procedure (Abstract).
In regards to claim 19, Isaacson et al does not teach wherein the light generating element comprises a luminescent coating applied on at least a portion of the instrument, the luminescent coating generating light after exposure to ambient light, as Isaacson et al instead teaches wherein the light generating element comprises one or more optical fibers 18, a sheath 22, and a light emitter 35. Pruitt et al teaches a system (Figures 1-4) wherein a light generating element comprises a luminescent coating (a coating of the light emitting substance 32) applied on at least a portion of an instrument (10), the luminescent coating generating light after exposure to ambient light (paragraph [0025]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the light generating element, of the system of Isaacson et al, to comprise a luminescent coating applied on at least a portion of the instrument, as taught by Pruitt et al, as such will emit visible light, to facilitate the ability to see the instrument as other devices or components are introduced into or attached onto a port outlined by the luminescent coating during a medical procedure (Abstract).
Claims 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al, as applied to claims 1 and 14 above, and further in view of Huo (CN 203139100).
In regards to claim 13, Isaacson et al is silent about wherein the housing is formed of a fluorescent plastic. Huo teaches a device (Figure 2) wherein a housing (20) is formed of a fluorescent plastic (paragraph [0016]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the housing, of the device of Isaacson et al, to be formed of a fluorescent plastic, as taught by Huo, as such will allow a doctor to not miss phenomenon because fluorescent plastic is very conspicuous (paragraph [0027]).
In regards to claim 20, Isaacson et al is silent about wherein the housing is formed of a fluorescent plastic. Huo teaches a system (Figure 2) wherein a housing (20) is formed of a fluorescent plastic (paragraph [0016]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the housing, of the system of Isaacson et al, to be formed of a fluorescent plastic, as taught by Huo, as such will allow a doctor to not miss phenomenon because fluorescent plastic is very conspicuous (paragraph [0027]).
Allowable Subject Matter
Claims 7-8, 10-11, and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Note: claim 8 is also rejected under 35 U.S.C. 112(b).
In regards to dependent claim 7, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of an instrument delivery device for use with an intravenous catheter assembly, as claimed, specifically including wherein the one or more LEDS are positioned on a distal end of the second portion of the advancement member, such that the one or more LEDS move with the advancement member when the advancement member is moved relative to the housing.
Isaacson et al teaches wherein the advancement member comprises a second portion (44) positioned within the inner volume, the second portion engaging the instrument (10) (Figures 5A-5B).
However, Isaacson et al does not teach wherein the advancement member comprises a first portion configured to move along an outer surface of the housing and the second portion connected to the first portion; and wherein the one or more LEDS are positioned on a distal end of the second portion of the advancement member, such that the one or more LEDS move with the advancement member when the advancement member is moved relative to the housing.
Devgon et al (US 10,300,247) teaches an instrument delivery device (Figures 1-29) for use with an intravenous catheter assembly, wherein an advancement member (270) comprises a first portion (271) configured to move along an outer surface of a housing (210) and a second portion (275) connected to the first portion and positioned within an inner volume, the second portion engaging an instrument (260).
However, Devgon et al does not teach wherein one or more LEDS are positioned on a distal end of the second portion of the advancement member, such that the one or more LEDS move with the advancement member when the advancement member is moved relative to the housing.
Thus, dependent claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1 and intervening claim 4. Dependent claim 8 is objected to by virtue of being dependent upon dependent claim 7. Note: claim 8 is also rejected under 35 U.S.C. 112(b).
In regards to dependent claim 10, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of an instrument delivery device for use with an intravenous catheter assembly, as claimed, specifically including a power circuit having an open state and a closed state, the power circuit providing power to the light generating element when in the closed state; wherein the power circuit is in the open state when the advancement member is in a home position, at the proximal end portion of the housing; and wherein the power circuit is transitioned from the open state to the closed state when the advancement member is moved distally from the home position, such that the light generating element receives power from the power circuit and is caused to emit light.
Isaacson et al does not teach a power circuit having an open state and a closed state, the power circuit providing power to the light generating element when in the closed state; wherein the power circuit is in the open state when the advancement member is in a home position, at the proximal end portion of the housing; and wherein the power circuit is transitioned from the open state to the closed state when the advancement member is moved distally from the home position, such that the light generating element receives power from the power circuit and is caused to emit light.
Thus, dependent claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1 and intervening claim 4. Dependent claim 11 is objected to by virtue of being dependent upon dependent claim 10.
In regards to dependent claim 18, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a catheter system, as claimed, specifically including a power circuit having an open state and a closed state, the power circuit providing power to the light generating element when in the closed state; wherein the power circuit is in the open state when the advancement member is in a home position, at the proximal end portion of the housing; and wherein the power circuit is transitioned from the open state to the closed state when the advancement member is moved distally from the home position, such that the light generating element receives power from the power circuit and is caused to emit light.
Isaacson et al does not teach a power circuit having an open state and a closed state, the power circuit providing power to the light generating element when in the closed state; wherein the power circuit is in the open state when the advancement member is in a home position, at the proximal end portion of the housing; and wherein the power circuit is transitioned from the open state to the closed state when the advancement member is moved distally from the home position, such that the light generating element receives power from the power circuit and is caused to emit light.
Thus, dependent claim 18 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim 14 and intervening claim 15.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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