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
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it fails to meet the 50 word minimum. Correction is required. See MPEP § 608.01(b).
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, 3-7, 10, 13-16, 19, and 21 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.
Claims 1 and 16 are rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
The claims are narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claims must be in one sentence form only. Note the format of the claims in the patents cited.
Claim 1 recites the limitations “the introducer” in line 4, and “the slot” in line 9. There is insufficient antecedent basis for these limitations in the claim. For the purposes of examination, claim 1 will be interpreted as “A method of placing a urinary catheter into the bladder of the female dog, comprising in combination: positioning the dog in the standing or in the lateral recumbency position, gently advancing an introducer into the vestibule and against the urethral orifice, feeding the urinary catheter through the introducer and into the urethral orifice, advancing the catheter so that the tip of the catheter resides in the bladder, observing urine flow, removing the introducer from the dog, and sliding the ex-dwelling portion of the urinary catheter body out of a slot in the introducer”.
Regarding claim 3, the phrase “the method of claim 1, further comprising a slot” is generally unclear. It appears that this claim is referring to the structure of the device, as opposed to the method that the device is used in. For the purposes of examination, claim 3 will be interpreted as “the method of claim 1, wherein a slot in the introducer is revealed prior to removing the urinary catheter from said introducer”.
Claim 4 recites the limitation "animal" in line 1. There is insufficient antecedent basis for this limitation in the claim, and the claim is generally unclear since a dog cannot also be a cat. For the purposes of examination, claim 4 will be interpreted as “the method of claim 1, wherein said method can also be used for a cat”.
Claim 5 recites the limitation “animal” in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, claim 5 will be interpreted as “the method of claim 1, wherein the dog is one of a mammal.”
Claim 6 recites the limitation “animal” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, claim 6 will be interpreted as “the method of claim 1, further comprising selecting the introducer based on the breed of the dog.”
Claim 7 recites the limitation “animal” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as “the method of claim 1, further comprising selecting the introducer based on the size of the dog”.
Claim 10 recites the limitation “animal” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as “the method of claim 1, wherein the position of the dog is based on the breed of the dog”.
Claim 13 recites the limitations “urinary catheter hub” in line 2 and “the Foley catheter body” in lines 2-3. There is insufficient antecedent basis for these limitations in the claim, and it is generally unclear as to what a “urinary catheter hub” is within the context of the disclosure. For the purposes of examination, the claim will be interpreted as “…wherein the inner diameter of the main body is smaller than the maximum size of the urinary catheter distal connection port but larger than the outside diameter of a Foley catheter body”.
Claim 14 recites the limitation “the urinary catheter is a Foley catheter” in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as “the device of claim 2, further comprising a urinary catheter, and the urinary catheter is a Foley catheter”.
Claim 15 recites the limitation "channel" in line 1. There is insufficient antecedent basis for this limitation in the claim. In this instance, it appears that “channel” is referring to the slot, as shown in figure 3. For the purposes of examination, the claim will be interpreted as “the device of claim 2, wherein the slot resides on the opposing side of the taper end”.
The limitation from the phrase “otoscope” in claim 17 is generally unclear, as an otoscope is generally used to examine a cavity of an ear. The instant application is directed towards examining a cavity within the urinary tract. As such, devices meant to examine a cavity in this area are often called cytoscopes. For the purposes of examination, claim 17 will be interpreted as “the device of claim 2, wherein the first end connects to an endoscope for visual placement.”
Claim 19 recites the limitation "the first end channels" in line 1. There is insufficient antecedent basis for this limitation in the claim. In this instance, it appears that “the first end channels” refer to the grooves between the finger grips as shown in figure 3. For the purposes of examination, the claim will be interpreted as “the device of claim 2, further comprising grooves on the first end of the device on the surface of the main body to allow one to hold the introducer and alter the angle in order to get into the correct position”.
Regarding claim 21, the phrase “further comprising a slot” is generally unclear, as this implies an additional slot which has not been disclosed. For the purposes of examination, the claim will be interpreted as “the device of claim 2, wherein the slot is revealed prior to removing the urinary catheter from said introducer”.
The above noted informalities should not be taken as an exhaustive list of all such instances. Therefore, it is requested that Applicant review the claims in their entirety for compliance with 35 U.S.C. 112(b).
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 pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 5 and 21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 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.
Regarding claim 5, the claim broadened the subject matter from claim 1. Claim 1 is a method meant for placing a urinary catheter into the bladder of a female dog, while claim 5 mentions placing the urinary catheter into the bladder of any mammal
Claim 20 fails to include all the limitations of the claim upon which it depends. Claim 2 requires a rim, and claim 20 removes the rim from claim 2.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
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 1 and 3-11 is rejected under 35 U.S.C. 103 as being unpatentable over SOP: Urinary Catheter in Dogs and Cats, University Veterinarian & Animal Resources, Virginia Tech (hereinafter “VT”) in view of Winegar (U.S. Patent Application # 20170265892).
Regarding claim 1, VT discloses a method of placing a urinary catheter into the bladder of a female dog; comprising in combination: positioning the dog in the standing or in the lateral recumbency position (IV(d)(i)(1)), gently advancing the introducer into the vestibule and against the urethral orifice (IV(d)(2)(b)(i), feeding the urinary catheter through the introducer and into the urethral orifice(IV(d)(2)(b)(iii), advancing the catheter so that the tip of the catheter resides in the bladder (IV(d)(iii)(1)(e), observing urine flow (IV(d)(iii)(1)(e), and removing the introducer from the dog (IV(d)(iii)(2)(a)(iii)), but fails to teach the method of sliding the ex-dwelling portion of the urinary catheter body out of a slot in the introducer. However, Winegar teaches a method of removing a cannula or catheter body (fig. 3D, cannula 300, paragraph 0068) out of a slot in the introducer (paragraph 0049).
Winegar is considered analogous art because it pertains to an introducer sheath for a catheter or cystoscope. It would have been obvious to anyone of ordinary skill in the art at the effective filing date of the invention to modify the method disclosed in VT with the teachings of Winegar in order to better remove the device from the patient without removing the catheter or cannula (see Winegar, paragraph 0049).
Regarding claim 3, VT, as modified by Winegar, disclose substantially the method disclosed in claim 1, but fails to teach wherein a slot in the introducer is revealed prior to removing the urinary catheter from said introducer. However, it would have been an obvious matter of design choice to have the slot be revealed prior to removing the urinary catheter from the introducer since the applicant has not disclosed that this difference solves any states problem or is for any particular purpose, and it appears that the invention would perform equally well when the slot is covered prior to removing the catheter (see Winegar, fig. 4).
Regarding claim 4, VT, as modified by Winegar, disclose the method wherein the animal could be a cat instead (see VT, IV(d)).
Regarding claim 5, VT, as modified by Winegar, disclose a method wherein the animal is a mammal (se VT, IV(b), IV(c), IV(d)).
Regarding claim 6, VT, as modified by Winegar, disclose substantially the method disclosed in claim 1, but fails to teach the method of selecting the introducers based on the breed of the dog. However, the major differences between various dog breeds are their size. It then would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the method disclosed in VT, as modified by Winegar, to select the introducer based on the breed of the dog since a modification of size would have been an obvious matter of design choice. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 7, VT, as modified by Winegar, disclose substantially the method disclosed in claim 1, but fails to teach the method of selecting the introducer based on the size of the animal. It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the method disclosed in VT, as modified by Winegar, to select the introducer based on the size of the dog since a modification of size would have been an obvious matter of design choice. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 8, VT, as modified by Winegar, disclose substantially the method disclosed in claim 1, but fails to teach the method further comprising selecting the introducer based on the type of urinary catheter. It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to select the introducer based on the type of catheter used since two cooperating parts should be sized respectively for cooperation.
Regarding claim 9, VT, as modified by Winegar, disclose wherein the urinary catheter and introducer are coupled together during insertion of the introducer (see Winegar, paragraph 0068 and fig. 3d).
Regarding claim 10, VT, as modified by Winegar, disclose substantially the method disclosed in claim 1, but fails to teach wherein the position of the animal is based on the breed of the animal. However, it would have been obvious to one of ordinary skill in the art at the effectivie filing date of the invention to modify the method to have the position of the dog depend on the breed, since VT discloses the use of multiple positions for the dog (IV(ad)(i)(1)), and it would be within the veterinarian’s best judgement to select the most convenient position.
Regarding claim 11, VT, as modified by Winegar, disclose the method wherein the introducer is removed from the dog, but not removed from the urinary catheter (see VT, IV(d)(iii)(2)(a)(iii)).
Claims 2, 15-16 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Collin (U.S. Patent Application # 201403365) in view of Magnusson (U.S. Patent Application # 20060200079).
• Regarding claim 2, Collin discloses a device for introduction of a urinary catheter (figure 1c, cannula 1) into the bladder of a female dog, which comprises in combination: a cylindrical main body (fig. 1c, cannula 1) including a first end (see annotated figure below) and a second end (see annotated figure below), a hole through the main body (see annotated figure below), the hole designed to allow a urinary catheter to pass through the main body (fig. 3a, catheter 11 inside cannula 1), a tapered second end to block off the vagina and allow for easy entry into the urethral orifice (see annotated figure below), a slot along the length of the main body extending through at least one wall of the main body (fig. 1c, slot 10) configured to allow a urinary catheter body to pass through the slot (fig. 3a, catheter 11), but fails to teach a rim, larger, than the cylindrical main body, positioned at the first end of the main body configured to prevent one’s fingers to advance along the main body towards the second end and between said rim. However, Magnusson teaches a drainage catheter sheath with a rim, larger than the cylindrical main body (fig. 8a, stopper 39 on sheath 36).
Magnusson is considered analogous art because it pertains to a sheath for a urinary catheter. It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the invention disclosed in Collin to have a rim to prevent the first end of the device from entering the body (see Magnusson, paragraph 0080).
• Regarding claim 15, Collin, as modified by Magnusson discloses wherein the channel resides on the opposing side of the taper end (see Collin, fig. 1C, slot 10).
• Regarding claim 16, Collin, as modified by Magnusson, discloses wherein the slot starts at the second end (see Collin, see annotated figure below).
• Regarding claim 22, Collin, as modified by Magnusson, discloses a device wherein the introducer in constructed out of plastic (see Collin, paragraph 0007).
• Regarding claim 23, Collin, as modified by Magnusson, Discloses substantially the device disclosed in claim 2, but it silent to wherein the tapered angle measures between 30 and 60 degrees.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Collin, as modified by Magnusson to have a tapered angle between 30 and 60 degrees 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 device of Collin, as modified by Magnusson, would not operate differently with the claimed tapered angle, since it would still be capable of blocking off the vagina and allowing easy access to the urethra. Further, applicant places no criticality on the range claimed, as the range between 30 and 60 degrees is generally broad.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over VT, as modified by Winegar as applied to claim 1 above, and further in view of Yoganathan (WO-2015148478).
Regarding claim 12, VT, as modified by Winegar, disclose substantially the method disclosed in claim 2, but fails to teach wherein the introducer is split in two halves to break away from the urinary catheter after placement. However, Yoganathan teaches a method of splitting the introducer in two halves (pg 24, lines 29-30, and pg. 25, lines 1-2) to break away from the urinary catheter after placement.
Yoganathan is considered analogous art because it pertains to an introducer for a catheter. It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the method disclosed in VT, as modified by Winegar, to split the introducer into two halves to allow the introducer to be removed from the guided part without needing to pull it through its whole length (see Yoganathan, pg. 24, lines 29-30, and pg. 25, lines 1-2).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Collin, as modified by Magnusson as applied to claim 2 above, and further in view of VT.
Regarding claim 13, Collin, as modified by Magnusson, discloses substantially the device as claimed in claim 2, and further discloses wherein the inner diameter of the main body is smaller than the maximum size of the urinary catheter hub (see Magnusson, fig. 8b, sheath 36 and connector 3) but larger than the outside of the diameter of the catheter body (see Magnusson, fig. 8b, sheath 31 and sheath 36), but fails to teach that the catheter is a Foley catheter. However, VT teaches that Foley catheters used in catheter introducers are known in the art. It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to substitute the pig-tail catheter disclosed in Collin, as modified by Magnusson, with a Foley catheter since they are art-recognized equivalents.
Regarding claim 14, Collin, as modified by Magnusson, discloses substantially the device as claimed in claim 2, but fails to mention that the urinary catheter used is a Foley catheter. However, VT teaches that Foley Catheters used in catheter introducers is known in the art.
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to substitute the pig-tail catheter disclosed in Collin to be a Foley catheter since they were art-recognized equivalents.
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Collin, as modified by Magnusson, in view of Winegar.
Regarding claim 17, Collin, as modified by Magnusson, discloses substantially the device disclosed in claim 2, but fails to teach wherein the first end connects to an endoscope for visual placement. However, Magnusson teaches an introducer wherein the first end connects to a cystoscope (fig. 3D, paragraph 0030 and 0068).
It would have been obvious to one of ordinary skill in the art to modify the introducer disclosed in Collin, as modified by Magnusson, to have a cystoscope attached to the first end of the introducer to pass said cystoscope through an anatomical space (see Winegar, paragraph 0004).
Regarding claim 19, Collin, as modified by Magnusson, discloses substantially the device disclosed in claim 2, but fails to teach a device further comprising grooves on the first end of the device on the surface of the main body to allow one to hold the introducer and alter the angle in order to get into the correct position. However, Winegar discloses an introducer with grooves on the first end of the device (paragraph 0053, also see annotated figure below).
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It would have been obvious to one of ordinary skill in the art to modify the device disclosed in Collin to have grooves on the first end of the device on the surface of the main body to provide better manipulation of the sheath (see Winegar, paragraph 0053).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Collin, in view of Magnussen, as applied to claim 2 above, and in further view of Bencini (U.S. Patent Application # 20080188800).
Regarding claim 18, Collin, as modified by Magnussen discloses substantially the device disclosed in claim 2, but fails to teach wherein the tapered end is less stiff than the main body. However, Bencini teaches a sheath for a catheter wherein the distal end is made of a more flexible material than the proximal end (paragraph 0008).
Bencini is considered analogous art because it pertains to an introducer assembly for introducing a catheter into the body. It would have been obvious to one of ordinary skill in the art to modify the device disclosed in Collin, as modified by Magnusson, to make the tapered end less stiff than the main body to promote steerability and provide better torque transmission properties at the proximal end (see Bencini, paragraph 0008).
Claim 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Collin, in view of Magnussen as applied to claim 2 above, and in further view of Copa (US 20090312696 A1).
Regarding claim 24, Collin discloses substantially the device disclosed in claim 2, but fails to teach wherein the first end terminates in a handle. However, Copa teaches an introducer wherein the first end terminates in a handle
Copa is considered analogous art because it pertains to treating tissue of the urinary tract. It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the device disclosed in Copa to have the first end terminate in a handle for one to grasp and manipulate the device and insert the device shat by manipulating the handle (see Copa, paragraph 0065)
Regarding claim 25, Collin discloses substantially the device disclosed in claim 2, but fails to teach wherein the first end terminates in a handle with a light source generating light that ravels to the second end. However, Copa teaches an introducer (fig. 12, shaft 403) wherein the first end terminates in a handle (fig. 12, body 412) with a light source (fig. 12, light source 416) generating light that travels to the second end (paragraph 0159).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the device disclosed in Collin to have a handle with a light source in order to illuminate the location of delivery (see Copa, paragraph 0091).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harmon (U.S. Patent # 7862542) discloses an introducer sheath for a catheter that has a tapered distal end.
McQuilkin (US Patent # 4888000) discloses an introducer for a catheter with a slot that is revealed prior to the catheter being removed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached on M-F 7:30 AM- 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas Weiss can be reached on (571) 270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brandon W. Levy/Examiner, Art Unit 3781
/Nicholas J. Weiss/Supervisory Patent Examiner, Art Unit 3781