DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Election/Restrictions
Applicant’s election without traverse of Invention I, drawn to an instrument for a bariatric procedure of claims 1-13 in the reply filed on 2/9/26 is acknowledged.
Claim(s) 14-20 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/136,407 (hereinafter “the ’407 application”), fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, claim 1 of the instant application recites “said source of illumination being configured for producing near infrared light into the patient's stomach when energized by an electrical power source, whereupon the position of said sizing tube within the patient's stomach can be readily visualized laparoscopically from outside the wall of patient's stomach by transillumination of the near infrared light passing through the wall of the patient's stomach.” However, this claimed subject matter is not described in the ‘407 application. As a result, the effective filing date of the instant application is 3/14/24.
Claim Objections
Claim 1 is objected to because of the following informalities: “for for” (line 1) appears that it should be “for.”
Claim 13 is objected to because of the following informalities: the claim is missing punctuation.
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(s) 3-4 is/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.
For claim 3, the claim language “wherein said near infrared light is in the range of approximately 780 nm to approximately 880 nm” is ambiguous. It is unclear how much is “approximately” 780 nm and “approximately” 880 nm. Does 779.99 nm and 880.01 get included? Does 779.9 nm and 880.1 get included? Does 779 nm and 881 nm get included? The claim is examined as meaning “wherein said near infrared light is in the range of 780 nm to 880 nm.”
For claim 4, the claim language “wherein said near infrared light is preferably approximately 850 nanometers” is ambiguous. It is unclear how much is “preferably” and “approximately” 850 nm. Does 849.99 nm and 850.01 get included? Does 849.9 nm and 850.1 get included? Does 849 nm and 851 nm get included? The claim is examined as meaning “wherein said near infrared light is 850 nanometers.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-2 and 8-13 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent Application Publication No. 2022/0354681 to Radl et al. (hereinafter “Radl”).
For claim 1, Radl discloses an instrument for (Examiner’s Note: functional language/intended use, i.e., capable of) a bariatric procedure on a patient (Abstract) having a stomach (para [0012]), the stomach having a wall (para [0012]), a greater curvature (para [0012]) and a lesser curvature (para [0012]), the patient also having an esophagus (para [0072]), said instrument comprising:
a sizing tube (22) (Fig. 1) (para [0064]) formed as an elongated unitary member of a flexible non-expandable material (para [0064]) having a predetermined outside diameter (para [0065]) configured for (Examiner’s Note: functional language/intended use, i.e., capable of) introduction through the esophagus into the patient's stomach so that a portion of said sizing tube is disposed along the lesser curvature of the patient's stomach (para [0065] and [0082]), said sizing tube having a longitudinal axis (“longitudinal axis,” para [0105]) and a circular cross-section having a circular outer surface (see Figs. 1 and 13), whereupon when said sizing tube is disposed along the lesser curvature of the patient's stomach the entire circular outer surface of said sizing tube is exposed for engagement by portions of the patient's stomach (para [0083], [0090], [0129], and [0131]), said sizing tube having a distal end portion (“distal end portion,” para [0027]), a proximal end portion (“proximal portion,” para [0027]), a hollow interior defining a passageway (“passageway,” para [0027]), and a plurality of apertures (30) (Fig. 1) (para [0066]) disposed about said circular outer surface at said distal end portion (as can be seen in Fig. 1), said sizing tube including a source of illumination extending along a portion of said longitudinal axis (“near infrared fluorescent dye,” para [0114], [0116]-[0117], [0119], and [0123]), said plurality of apertures being directed in a plurality of different radial directions extending at an angle greater than zero degrees from each other measured about said longitudinal axis (as can be seen in Fig. 1) (also see para [0072]) and being in fluid communication with said passageway (para [0066]), plural ones of said apertures extending along a portion of the lesser curvature of the patient's stomach when said sizing tube is located within the patient's stomach (Examiner’s Note: functional language/intended use, i.e., capable of) (as can be seen in Fig. 1) (also see para [0082]), said instrument being configured for (Examiner’s Note: functional language/intended use, i.e., capable of) providing controlled suction to said passageway and through said apertures to pull the lesser curvature of the patient's stomach into engagement with a portion of said circular outer surface of said sizing tube and contemporaneously therewith to pull other portions of the patient's stomach adjacent to said sizing tube towards portions of said circular outer surface of said sizing tube not facing the lesser curvature of the patient's stomach to produce a suction-created visually perceptible delineation line on the exterior of the patient's stomach along a portion of said circular outer surface of said sizing tube facing the greater curvature of the patient's stomach (para [0073], [0083]-[0085], [0087], and [0089]), said source of illumination being configured for (Examiner’s Note: functional language/intended use, i.e., capable of) producing near infrared light into the patient's stomach when energized by an electrical power source (para [0114], [0116]-[0117], [0119], and [0123]), whereupon the position of said sizing tube within the patient's stomach can be (Examiner’s Note: capable of) readily visualized laparoscopically from outside the wall of patient's stomach by transillumination of the near infrared light passing through the wall of the patient's stomach (para [0114]-[0115]).
For claim 2, Radl further discloses wherein said source of illumination is an elongated source of illumination located within said sizing tube and extending along a portion of said longitudinal axis at said distal end portion (para [0114], [0116]-[0117], [0119], and [0123]).
For claim 8, Radl further discloses wherein said sizing tube is configured to permit flexing of thereof perpendicular to said longitudinal axis while preventing longitudinal collapse thereof due to perpendicular flexion (para [0129]).
For claim 9, Radl further discloses comprising a spring located in said distal end portion of said sizing tube, said spring being configured to permit flexing of said sizing tube perpendicular to said longitudinal axis while preventing longitudinal collapse of said sizing tube due to perpendicular flexion (para [0129]).
For claim 10, Radl further discloses wherein said sizing tube includes at least one one-way valve (para [0104]-[0108]), said at least one one-way valve being automatically closed when controlled suction is applied to said passageway (para [0104]-[0108]), said at least one one-way valve being openable to enable a fluid to be passed therethrough from the interior of said sizing tube into the stomach of the patient to prevent said sizing tube from becoming stuck in the patient's stomach (para [0104]-[0108]).
For claim 11, Radl further discloses wherein said at least one one-way valve comprises a slit in said sidewall (para [0105]-[0107]).
For claim 12, Radl further discloses wherein said instrument comprises a portion of a system (para [0078]-[0080]), said system additionally comprising a suction controller configured to apply controlled suction from a source of suction to said passageway of said sizing tube to result in a force in a range of 0.05 to 200 pounds anchoring said sizing tube in position within the patient's stomach (para [0078]-[0080]).
For claim 13, Radl further discloses wherein said sizing tube is configured to apply a suction force per unit length within the patient's stomach at the location of said apertures when said controlled suction is applied to said passageway (para [0079]-[0080]), whereupon the suction force applied per unit length is in a range of 0.02 to 21 pounds per inch (para [0080]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 3-4 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Radl.
For claim 3, Radl does not expressly disclose wherein said near infrared light is in the range of approximately 780 nm to approximately 880 nm.
However, Radl teaches wherein said near infrared light is “within a wavelength range of approximately 700 nm to 1300 nm” (para [0116]).
It would have been obvious to a skilled artisan to modify Radl wherein said near infrared light is in the range of approximately 780 nm to approximately 880 nm, in view of the teachings of Radl, because it has been held that where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
For claim 4, Radl does not expressly disclose wherein said near infrared light is preferably approximately 850 nanometers.
However, Radl teaches wherein said near infrared light is “within a wavelength range of approximately 700 nm to 1300 nm” (para [0116]).
It would have been obvious to a skilled artisan to modify Radl wherein said near infrared light is preferably approximately 850 nanometers, in view of the teachings of Radl, because it has been held that where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 5-7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Radl in view of U.S. Patent Application Publication No. 2022/0151724 to Szoka.
For claim 5, Radl does not expressly disclose wherein said elongated source of illumination comprises a flexible circuit including plural spaced-apart near infrared light emitting diodes.
However, Szoka teaches wherein said elongated source of illumination comprises a flexible circuit including plural spaced-apart near infrared light emitting diodes (44 on 40) (Fig. 2) (para [0033]).
It would have been obvious to a skilled artisan to modify Radl wherein said elongated source of illumination comprises a flexible circuit including plural spaced-apart near infrared light emitting diodes, in view of the teachings of Szoka, because such a modification would be the addition or substitution of a different type of source of illumination that would yield the predictable result of illuminating the surrounding area to improve visualization during a medical procedure.
For claim 6, Radl does not expressly disclose wherein said instrument additionally comprises at least one light emitting diode for producing light at a visible frequency to provide an indication of said source of illumination producing said near infrared light.
However, Szoka wherein said instrument additionally comprises at least one light emitting diode for producing light at a visible frequency to provide an indication of said source of illumination producing said near infrared light (“white light and/or near-infrared light,” para [0033]).
It would have been obvious to a skilled artisan to modify Radl wherein said instrument additionally comprises at least one light emitting diode for producing light at a visible frequency to provide an indication of said source of illumination producing said near infrared light, in view of the teachings of Szoka, because such a modification would be the addition a different type of source of illumination that would yield the predictable result of illuminating the surrounding area to improve visualization during a medical procedure.
For claim 7, Radl does not expressly disclose wherein the electrical power source is an electrical battery, wherein said instrument comprises said electrical battery, and wherein said electrical battery is connected to said source of illumination.
However, Szoka teaches wherein the electrical power source is an electrical battery (para [0034]), wherein said instrument comprises said electrical battery (para [0034]), and wherein said electrical battery is connected to said source of illumination (para [0034]).
It would have been obvious to a skilled artisan to modify Radl wherein the electrical power source is an electrical battery, wherein said instrument comprises said electrical battery, and wherein said electrical battery is connected to said source of illumination, in view of the teachings of Szoka, for the obvious advantage of portably powering the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791