DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
The application comprises claims directed to the following patentably distinct species:
A Species must be elected from Set I:
Set I:
Species A: The physical device as discussed with reference to Fig.1
Species B: The physical device as discussed with reference to Fig.2
Species C: The physical device as discussed with reference to Fig.7
Species D: The physical device as discussed with reference to Fig.11
Species E: The physical device as discussed with reference to Fig.12
A Species must be elected from Set II:
Set II:
Species F: Where the method is part of a Heller Myotomy (esophogeal)
Species G: Where the method is part of a hiatal hernia repair (stomach)
Species H: Where the method is part of a sleeve gastroectomy
Species I: Where the method is part of a gastric and esophageal tumour survey
Species J: Where the method is part of a gastric bypass
Species K: Where the method is part of a rectal surgery
Species L: Where the method is part of a colon surgery
Species M: Where the method is part of a surgery on a urologic organ
Species N: Where the method is part of a surgery on a gynecological organ
Note: these 2 species to be elected shall together constitute a single grouping of patentably indistinct species.
These species are independent or distinct because they have mutually exclusive characteristics, thus having a search and/or examination burden by requiring different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries) and the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. Further, the prior art applicable to one species would not likely be applicable to another species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, no claims are held to be generic. Further, applicants are required to point out which claims correspond with which species, including new or amended claims.
There is a search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the species require a different field of search due to their mutually exclusive characteristics (for example, searching different classes/subclasses or electronic resources, or employing different search queries)
(b) the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of inventions (ii) an election of a species or a grouping of patentably indistinct species to be examined even though the requirement may be traversed (37 CFR 1.143). and (iii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with John Hemmer on 10 April, 2026 a provisional election was made without traverse to prosecute the invention of Species D, the physical device described in Fig.11, and J, where the method is part of a gastric bypass, directed to claims 51-53, 57, 59-66 and 68-71. Affirmation of this election must be made by applicant in replying to this Office action. Claims 54-56, 58 and 67 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to non-elected species.
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 52-53, 57, 59, 65 and 71 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 pre-AIA the applicant regards as the invention.
In regards to claims 52, 65 and 71, the claims read “or a combination thereof” [claims 52 and 71] and “or any combination thereof” [claim 65]. For claim 52, this is included after a list of two items. Therefore, it is unclear if these combinations as set forth by the applicant require one or more items of the list, or two or more items from the list. Therefore, the claims are unclear.
For the purposes of prosecution, it will be assumed the former is the case.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 59 is rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regards to claim 59, the claim reads “adjacent light sources in the plurality of light sources or adjacent markings in the plurality of markings are spaced apart evenly along the length direction of the elongated member of the lighted device”,
whereas claim 52, from which it depends, reads “adjacent light sources in the plurality of light sources are spaced apart along a length direction of the elongated member at a first predetermined interval” and “adjacent markings in the plurality of markings are spaced apart along the length direction of the elongated member at a second predetermined interval”.
As such, claim 59 fails to further limit the subject matter of claim 52 from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 51-53, 59-60, 62, 65, 68 and 70-71 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Kruglick et al. (US 2013/0289362).
In regards to Claim 51, Kruglick discloses a method for using a lighted device in a surgical procedure, wherein the lighted device comprises an elongated member [224, 342, Figs.2-3, para.26-27, 31] and at least one light source [“LEDs”, 344, 346, Fig.3, para.26-27, 31-32] coupled to the elongate member, the method comprising:
inserting at least a first portion [226, Fig.2, para.28] of the elongated member of the lighted device into an operative field of a patient [Fig.2];
illuminating the operative field with a light emitted from the at least one light source disposed at the elongate member of the lighted device [para.27-28, 31-32];
capturing one or more images of the operative field while the first portion of the elongated member of the lighted device is in the operative field with an image capturing device [234, Fig.2, para.27-30] disposed outside the operative field; and
determining a location of the first portion of the elongated member of the lighted device in the operative field of the patient based on the one or more images captured by the image capturing device [para.28].
In regards to claim 52, Kruglick discloses the method of claim 51, wherein:
the at least one light source comprises a plurality of light sources [346, Fig.3, para.32] disposed at the first portion of the elongated member, wherein adjacent light sources in the plurality of light sources are spaced apart along a length direction of the elongated member at a first predetermined interval;
the lighted device comprises a plurality of markings [344 and distal 346, Fig.3, para.32] disposed at the first portion of the elongated member, wherein adjacent markings in the plurality of markings are spaced apart along the length direction of the elongated member at a second predetermined interval;
or a combination thereof [note the 112 (b) rejection hereinabove].
In regards to claim 53, Kruglick discloses the method of claim 52, further comprising:
using at least the first portion of the elongated member of the lighted device as a guide or calibration tool to perform one or more intraoperative measurements [para.29, 30].
In regards to claim 59, Kruglick discloses the method of claim 52, wherein adjacent light sources in the plurality of light sources or adjacent markings in the plurality of markings are spaced apart evenly along the length direction of the elongated member of the lighted device [as discussed in the rejection of claim 52 hereinabove. Also see the 112 (d) rejection of claim 59 hereinabove.].
In regards to claim 60, Kruglick discloses the method of claim 52, wherein the plurality of light sources is configured to emit light in a first wavelength range [one range within 700-870nm, para.27] that is able to transmit through one or more first tissues of the patient but unable to transmit through one or more second tissues of the patient and a second wavelength range [another range within 700-870nm, para.27] that is able to transmit through both the one or more first tissues and the one or more second tissues of the patient [such tissues exist within patients: the claim requires wavelength ranges stated in a peculiar fashion].
In regards to claim 62, Kruglick discloses the method of claim 52, wherein the plurality of light sources comprises five or more light sources [Fig.3, para.31-32].
In regards to claim 65, Kruglick discloses the method of claim 51, wherein the at least one light source comprises at least one LED light [para.27-28, also see the 112 (b) rejection of claim 65 hereinabove].
In regards to claim 68, Kruglick discloses the 68. (New) The method of claim 51, wherein the lighted device further comprises a handle [proximal end of 224, Fig.2], wherein the elongate member extends from the handle.
In regards to claim 70, Kruglick discloses the method of claim 51, wherein the operative field comprises an esophagus and/or stomach of the patient [Figs.1-2, para.22, 55].
In regards to claim 71, Kruglick discloses the method of claim 51, wherein the image capturing device comprises a near-infrared camera [234, Fig.2, para.27, also see the 112 (b) rejection of claim 71 hereinabove].
Claims 51, 65 and 68 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Adajar (US 2017/0156756).
In regards to claim 51, Adajar discloses a method for using a lighted device in a surgical procedure, wherein the lighted device comprises an elongated member [100, Figs.1-4, para.33] and at least one light source [134, Figs.1-3, para.36] coupled to the elongate member, the method comprising:
inserting at least a first portion of the elongated member of the lighted device into an operative field of a patient [Fig.4];
illuminating the operative field with a light emitted from the at least one light source disposed at the elongate member of the lighted device [para.36];
capturing one or more images of the operative field while the first portion of the elongated member of the lighted device is in the operative field with an image capturing device [“camera”, para.33, 36] disposed outside the operative field; and
determining a location of the first portion of the elongated member of the lighted device in the operative field of the patient based on the one or more images captured by the image capturing device [para.36].
In regards to claim 65, Adajar discloses the method of claim 51, wherein the at least one light source comprises at least one optic fiber [para.36: also see the 112 (b) rejection of claim 65].
In regards to claim 68, Adajar discloses the method of claim 51, wherein the lighted device further comprises a handle [110, Fig.2, para.33], wherein the elongate member extends from the handle [Fig.2].
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 61 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Kruglick et al. (US 2013/0289362) in view of Dowling et al. (US 2005/0099824).
In regards to claim 61, Kruglick discloses the method of claim 60, wherein the second wavelength range is about 700 nm to about 850 nm [para.27: within 700-870],
however does not disclose wherein the first wavelength range is about 400 nm to about 650 nm.
Kruglick further discloses where the method is an endoscopic transilluminating method [para.27].
Dowling discloses that in an endoscopic transilluminating method [para.260] utilizing plural LEDs [para.260], plural light sources employed may be configured to generate white and near-infrared light [para.81, 93-94, 260].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the at least one light source used in the method of Kruglick to be configured to generate both white light and near-infrared light in accordance with the teaching of Dowling. This would be done as Dowling shows that this is a feature known in the art.
This results in a method where a first wavelength range emitted by the plural light sources would include a range about 400 nm to about 650 nm, as this is within the range of white light, and as applicant’s strict definition of “about” includes subsets of this range: see in particular applicant’s paragraph 51.
In regards to claim 63, Kruglick discloses the method of claim 51, wherein the at least one light source is configured to generate a near-infrared light [para.27].
Kruglick further discloses where the method is an endoscopic transilluminating method [para.27] where the at least one light source is plural LEDs [para.27].
However, Kruglick does not positively disclose wherein the at least one light source is also configured to generate a white light.
Dowling discloses that in an endoscopic transilluminating method [para.260] utilizing LEDs [para.260], plural light sources employed may be configured to generate white and near-infrared light [para.81, 93, 260].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the at least one light source used in the method of Kruglick to be configured to generate both white light and near-infrared light in accordance with the teaching of Dowling. This would be done as Dowling shows that this is a feature known in the art.
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Kruglick et al. (US 2013/0289362) in view of LaBombard (US 2015/0230782).
In regards to claim 66, Kruglick discloses the method of claim 51, however does not positively disclose wherein the elongate member of the lighted device has a diameter of 34 French, 36 French, 38 French, or 40 French, or a length of about 32 inches,
or particularly describe the dimensions of the elongated member.
Kruglick further discloses wherein the elongate member is a flexible endoscope used in a gastric procedure [Figs.2-3, para.31, 64].
LaBombard teaches that a flexible endoscope used in a gastric procedure may have a diameter of 36 French [para.4: 36 French is 12 mm].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the elongate member used in the method of Kruglick to have a diameter of 36 French in accordance with the teaching of LaBombard. This would be done as LaBombard shows that such diameters are known as appropriate in the art.
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Kruglick et al. (US 2013/0289362) in view of Wang et al. (US 5,553,198).
In regards to claim 69, Kruglick discloses the method of claim 51, however does not positively disclose wherein the surgical procedure is a robotic assisted surgery.
Kruglick further discloses wherein the method is laparoscopy [abstract, para.2, 31, 64].
Wang discloses wherein laproscopy may be robotic assisted surgery [abstract, Fig.1, col.3 ll.20-28].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the surgical procedure to be a robotic assisted surgery in accordance with the teaching of Wang. This would be done for the predictable result of more precise control of medical instruments.
Allowable Subject Matter
Claim 64 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 and any intervening claims.
Claim 57 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112, 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: The prior art fails to teach, among other features, a surgical procedure comprising the steps of:
insert a first portion of an elongated member of a lighted device into an operative field of a patient;
illuminate the operative field with light emitted from a light source coupled to the elongated member;
with an image capturing device disposed outside of the operative field, capture at least one image of the operative field while the first portion is in the operative field; and
determine a location of the first portion in the operative field of the patient based on the at least one image captured by the image capturing device,
(claim 57) wherein
either the light source comprises plural light sources disposed at the first portion of the elongated member, wherein adjacent light sources of this plurality are spaced apart along a length direction of the elongated member,
and/or the lighted device comprises plural markings in the first portion, adjacent markings of the plural markings spaced apart along a length direction of the elongated member,
and the surgical procedure is a gastric bypass, the elongated member used as a guide or calibration tool in creating a gastric pouch during the gastric bypass,
(claim 64) wherein the light source is configured to generate white and near-infrared light,
wherein the step of illuminating comprises alternating illuminating with the white and near-infrared light.
Angelchik (US 5,624,432) teaches the independent claim except for image capture.
Valley et al. (US 5,795,325) teaches the independent claim except for image capture.
Snow (US 2001/0010247) teaches the independent claim except for image capture.
Goldfarb et al. (US 2007/0167682) teaches the independent claim except for image capture.
Bonutti (US 2014/0228679) teaches the independent claim except for image capture.
Hayut et al. (US 2016/0227991) teaches the independent claim, except instead teaching the image capturing device is on an elongated member in the operative field, and the light source is on a separate device outside the operative field.
Adajar (US 2017/0156756) discloses the above except for the particulars of the discussed dependent claims.
Kruglick et al. (US 2013/0289362) discloses the above except for
(claim 57) the underlined portion
(claim 64) that the light source is configured to generate white light.
Dowling et al. (US 2005/0099824) discloses that both white and red light may be used together in endoscopic transilluminating methods.
Ortiz (US 2007/0032702) discloses that endoscopes may be used in gastric bypass procedures.
In obvious combination, Kruglick and Dowling teach
(claim 64) except for the underlined portion.
In obvious combination, Kruglick and Ortiz teach
(claim 57) except for that the elongated member is used as a guide or calibration tool in creating a gastric pouch during the gastric bypass.
There is no reason or suggestion provided in the prior art to modify the above prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Valley et al. (US 5,795,325)
Snow (US 2001/0010247)
Ortiz (US 2007/0032702)
Goldfarb et al. (US 2007/0167682)
Bonutti (US 2014/0228679)
Hayut et al. (US 2016/0227991)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON B FAIRCHILD whose telephone number is (571)270-5276. The examiner can normally be reached 8:30am-5pm Monday-Friday.
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, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON B FAIRCHILD/Primary Examiner, Art Unit 3795
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