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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10 & 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For claims 10 & 21, the limitation is not supported in the original specification. The sleeve body appears to be attached at its ends by sewn with threads as stated in paragraphs 0021,0027,0035 of the specification and shown in fig. 3. Threads are considered to be fasteners because they fastened ends of a material together. In the remarks filed 4/20/2026, applicant stated that “Paragraph 0005 of the specification describes existing devices that may include a "hook-and-loop fastener (e.g., Velcro)." Paragraph 0005 goes on to describe the disadvantages of hook-and-loop fasteners, such as sticking to the animal's hair and/or reducing reusability of the device. By contrast, paragraph 0024 of the specification recites that "[i]n some implementations, the material of the neck band ... has no fasteners." Therefore, the sleeve body being "devoid of fasteners" (e.g., without a hook-and-loop fastener) is clearly supported by the specification and the drawings as originally filed.”; however, this does not prove that the limitation is supported.
First, the limitation stated that the sleeve body is devoid of fasteners which is not true because the edges of the sheath are sewn together with threads as shown in fig. 3, so the limitation does not hold.
Second, while para. 0005 stated the disadvantages of hook and loop fasteners, this has nothing to do with the limitation of “devoid of fasteners”. Not selecting to use hook and loop fasteners does not mean that the sleeve is devoid of “other” fasteners such as the threads.
Third, para. 0024 is broad and unclear because it states: “In some implementations, the material of the neck band allows for good airflow, does not restrict movement of the head, has no fasteners, and/or allows for the feeding adaptor to be easily accessed while remaining secure when not in use.”, which it is unclear what is meant by “some implementations”? Tying this to para. 0005 discussion of hook and loop fasteners, is “no fasteners” meant for hook and loop fasteners or other fasteners because clearly shown in fig. 3 of applicant’s drawing, threads are being used to sewn the edges of the sleeve body. In addition, the paragraph seems to state “the material” has no fasteners, which the material, itself, is a fabric that are woven together and already made; thus, of course, there is no fasteners. Furthermore, the paragraph is unclear as to why it states that the material…has no fasteners? Lastly, the paragraph appears to contradict the detailed description of the invention and the drawings because clearly from figs. 1C,3, threads are being used to sewn the edges of the sleeve body together, and the sleeve body is NOT one continuous piece of material without any interruption or break, which applicant has deleted from the claims due to a previous 112(a) rejection in the previous Office action. The only way this limitation is supported is if applicant originally stated that the sleeve body is one continuous piece of material without any interruption or break, which applicant did not state as such.
Thus, it is concluded that the limitation is not supported in the original specification and appears to be a new matter issue.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1,5-14,19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Dula-White (US 11638662 B2) in view of Shesol et al. (US 5897519 A) and Denicola et al. (US 4688270 A).
For claim 1, Dula-White teaches a device for retaining an implanted medical device, the device comprising:
a sleeve body (100) forming a cylindrical shape extending circumferentially around a first longitudinal axis, the sleeve body comprising an inner surface that defines a main channel (fig. 1 where ref. 104 is pointing at is considered an inner surface that defines a main channel; also, fig. 2 ref. 200 shows the inner surface), the sleeve body defining a cranial opening (104) on a first end of the main channel and a caudal opening (106) on a second end of the main channel, wherein the second end is spaced apart from the first end of the sleeve body along the first longitudinal axis of the sleeve body (fig. 1, self-explanatory), wherein the sleeve body comprises a stretchable, breathable fabric (col. 3, lines 30-35, esp. spandex) configured to slide over a head and onto a neck of an animal (functional recitation to which Dula-White stated that the sleeve body can be slid over a body part of the animal in col. 5, lines 24-25), wherein the sleeve body is devoid of hook and loop fasteners (col. 5, lines 1-8 state that one can use other fasteners instead of hook and loop fasteners, thus, would be devoid of hook and loop fasteners); and
a fastener (212) coupled to a middle of a length of the sleeve body between the first and second ends (fig. 2), the fastener extending from the inner surface of the sleeve body into the main channel of the sleeve body, wherein the fastener is configured to receive and retain a wound care component.
In the event that applicant disagrees with the examiner’s interpretation of Dula-White teaching the body part in which the sleeve body functionally “configured to slide over a head and onto a neck of an animal”, Shesol et al. teach in the same field of endeavor of a device for retaining an implanted medical device comprising a sleeve body (12) comprises a stretchable, breathable fabric (col. 4, lines 54-56) that is used on a neck of an animal (fig. 9). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the sleeve body of Dula-White for the neck area of the animal as taught by Shesol et al., depending on the injured body part because Dula-White stated that the sleeve body can be applied to any other body part including the upper, lower, or both parts of the body part. In addition, Since Dula-White teaches that the sleeve body can be slid over the animal per col. 5, lines 24-25, the sleeve body of Dula-White as modified by Shesol et al. would result in performing the functional recitation of “configured to slide over a head and onto a neck of an animal”.
Dula-White is silent about a sheath, wherein the sheath extends circumferentially around a second longitudinal axis to define a secondary channel, the sheath defining a first sheath aperture on a first end of the secondary channel and a second sheath aperture on a second end of the secondary channel, wherein the second end of the secondary channel is spaced apart from the first end of the secondary channel along the second longitudinal axis of the sheath, wherein the sheath is configured to receive and retain an esophagostomy tube.
Denicola et al. teach in the same field of endeavor of a device for retaining an implanted medical device comprising a sheath (40), wherein the sheath extends circumferentially around a second longitudinal axis to define a secondary channel (fig. 1 shows the sheath 40 forming a channel for tube 37), the sheath defining a first sheath aperture on a first end of the secondary channel (fig. 1 at ref. 40) and a second sheath aperture on a second end of the secondary channel (fig. 1 at ref. 40), wherein the second end of the secondary channel is spaced apart from the first end of the secondary channel along the second longitudinal axis of the sheath, wherein the sheath is configured to receive and retain an esophagostomy tube (functional recitation to which the sheath of Denicola et al. can and does perform the intended function to receive and retain tube 37). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to employ a sheath with the features as described above of Denicola et al. as the fasteners for the wound care component of Dula-White, in the event the user wishes to use an esophagostomy tube or an intravenous line as a wound care component for the animal so that the sheath can hold the tube for such treatment.
For claim 5, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, and further teaches wherein the sleeve body comprises an integrally formed elastic fabric material (col. 3, lines 34-35 of Dula-White, spandex).
For claim 6, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, and further teaches wherein the device is a neckband device configured to be disposed on the neck of the animal (as modified with Shesol), wherein the sheath is configured to receive and retain the esophagostomy tube (as modified with Denicola et al.), which is implanted in and extends from the neck of the animal.
For claim 7, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, but is silent about wherein the sheath is coupled to the inner surface of the sleeve body with at least one sewn thread. In addition to the above, Denicola et al. stated that the sheath (40) is sewn onto the inner surface of the sleeve body (col. 4, lines 63-68). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the sheath of Dula-White as modified by Shesol et al. and Denicola et al. be coupled to the inner surface of the sleeve body with at least one sewn thread as further taught by Denicola et al. in order to couple the sheath to the sleeve body because sewing with threads is better for fabric material that other fasteners so as to give the fabric material structure, durability and aesthetic appeal.
For claim 8, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, and further teaches wherein a circumference of the sleeve body measured around the first longitudinal axis is in a range of 9 to 20 inches (col. 3, lines 48-52 of Dula-White).
For claim 9, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, and further teaches wherein a height of the sleeve body measured from the first end to the second end of the sleeve body is in a range of 4 to 10 inches (col. 3, lines 48-52 of Dula-White).
For claim 10, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, and further teaches wherein the sleeve body is devoid of fasteners (col. 5, lines 24-29 of Dula-White states that the sleeve may be slid onto the user’s body part OR the sleeve can have fasteners to be held onto the body part, which the first option would be devoid of fasteners; also, as stated in the above 112 rejection, applicant’s invention is not devoid of fasteners for the sleeve body because it is clearly shown in fig. 3 that there is a seam to connect the edges of the sleeve body).
For claim 11, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, and further teaches wherein the sleeve body is stretchable (the sleeve body in Dula-White can be spandex) between: (i) a first configuration having a first circumference measured along the sleeve body around the first longitudinal axis (the circumference at ref. 106; also, implied in Dula-White when the user applies the sleeve body over the neck of a user as modified with Shesol); and (ii) a second configuration having a second circumference measured along the sleeve body around the first longitudinal axis (the circumference at ref. 104; also, implied in Dula-White when the user applies the sleeve body over the neck of a user as modified with Shesol), wherein the second circumference is larger than the first circumference (fig. 1 of Dula-White shows the second circumference 104 being larger than the first circumference 106).
For claim 12, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 11, and further teaches wherein a first height of the sleeve body measured from the first end to the second end of the main channel in the first configuration is greater than a second height of the sleeve body in the second configuration (as shown in fig. 1 of Dula-White).
For claim 13, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 11, and further teaches wherein the sleeve body is movable between: (i) a placement configuration defined by the inner surface of the sleeve body being adjacent to the neck of the animal with an outer surface of the sleeve body facing away from the neck of the animal, wherein the sheath is disposed entirely within the main channel of the sleeve body (as result in the combination of Dula-White as modified by Shesol et al. and Denicola et al., with the neck concept taught by Shesol and the sheath inside the sleeve body as taught by Denicola); and (ii) an access configuration defined by a section of the sleeve body being folded outwardly from the first longitudinal axis to expose a portion of the inner surface of the sleeve body such that at least a portion of the sheath is accessible (implied in the combination of Dula-White as modified by Shesol et al. and Denicola et al. because the user as to access the sheath and the tube therein for cleaning and maintenance).
For claim 14, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 13, and further teaches wherein, in the access configuration, an esophagostomy tube (as relied on with Denicola) may be inserted into or removed from the sheath and a surgical site may be inspected and cleaned (Dula-White teaches that the user will need to access the wound to clean and such, for example, col. 2, lines 55-60, col. 3, lines 10-17, col. 6, lines 38-44).
For claim 19, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, and further teaches wherein the sleeve body comprises a stretch woven fabric capable of at least 20 % stretch in either warp or filling direction (Dula-White teaches spandex which is known to stretch at least 20%). However, in the event that applicant disagrees with the examiner’s interpretation that spandex is capable of stretching at least 20%, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the spandex of Dula-White as modified by Shesol et al. and Denicola et al. be capable of stretch of at least 20 % stretch in either warp or filling direction, depending on the degree of flexibility or stretchability the user wishes to employ for the sleeve body to be slid over the user, since it has been held that where routine testing and general experimental conditions are present, discovering the optimum or workable ranges until the desired effect is achieved involves only routine skill in the art. In re Aller, 105 USPQ 233.
For claim 20, Dula-White as modified by Shesol et al. and Denicola et al. teaches a method of retaining a medical device implanted on the neck of a living subject, the method comprising:
providing the retaining device as explained in the above claim 1;
placing the retaining device on the neck of the animal by stretching out a circumference of the sleeve body to fit over the head of the animal (the neck concept is as modified with Shesol, and fitting over the head and neck or sliding the sleeve body concept is taught by Dula-White per col. 5, lines 24-25);
folding back a section of the sleeve body to expose a portion of the inner surface of the sleeve body and the sheath (implied in the combination of Dula-White as modified by Shesol et al. and Denicola et al. because the user has to fold the sleeve body to access the sheath and the tube; also, Dula-White stated that the interior of the sleeve body will need to be access for cleaning and such per col. 2, lines 55-60, col. 3, lines 10-17, col. 6, lines 38-44); and
inserting the medical device into the sheath (implied in the combination of Dula-White as modified by Shesol et al. and Denicola et al. because Denicola teaches the sheath holding medical device 37, and Dula-White teaches that the sleeve body can hold a wound care component inside the interior surface, which the medical device 37 of Denicola can be a wound care component).
For claim 21, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, and further teach wherein the sleeve body is devoid of fasteners. (col. 5, lines 24-29 of Dula-White states that the sleeve may be slid onto the user’s body part OR the sleeve can have fasteners to be held onto the body part, which the first option would be devoid of fasteners; also, as stated in the above 112 rejection, applicant’s invention is not devoid of fasteners for the sleeve body because it is clearly shown in fig. 3 that there is a seam to connect the edges of the sleeve body).
For claim 22, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 20, and further teach moving the sleeve body from a placement configuration to an access configuration by folding a section of the sleeve body outwardly from the first longitudinal axis to expose a portion of the inner surface of the sleeve body such that at least a portion of the sheath is accessible (implied in the combination of Dula-White as modified by Shesol et al. and Denicola et al. because the user as to access the sheath and the tube therein for cleaning and maintenance, thus, would perform the step of moving the sleeve body as claimed); inspecting or cleaning an entry site of the medical device on the neck of the living subject (Dula-White teaches inspecting and cleaning per col. 2, lines 55-60, col. 3, lines 10-17, col. 6, lines 38-44); and moving the sleeve body from the access configuration to the placement configuration by folding the section of the sleeve body inwardly toward the first longitudinal axis to conceal the portion of the inner surface of the sleeve body, wherein the sheath is disposed entirely within the main channel of the sleeve body (implied in the combination of Dula-White as modified by Shesol et al. and Denicola et al. because the user as to fold or put the sleeve body back to cover the medical device, thus, would perform the step of moving the sleeve body as claimed).
Claims 2,16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dula-White as modified by Shesol et al. and Denicola et al. as applied to claim 1 above, and further in view of Hidalgo (US 9775971 B2).
For claim 2, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, but is silent about wherein the first longitudinal axis is substantially perpendicular to the second longitudinal axis.
Hidalgo teaches in the same field of endeavor of a device for retaining an implanted medical device comprising a sleeve body (20) extending continuously and circumferentially around a first longitudinal axis (when the sleeve body is coupled with the coupling assembly 24,38,42, the sleeve body will be a loop and extending continuously and circumferentially around a first longitudinal axis), the sleeve body comprising a continuous inner surface that defines a main channel (as stated, when the sleeve body is in closed configuration by coupling the ends of the sleeve with the coupling assembly 24,38,42, a main channel is created), the sleeve body defining a first aperture on a first end of the main channel (the first aperture can be the entry aperture to the main channel when the sleeve body is in closed configuration as stated in the above) and a second aperture on a second end of the main channel (the second aperture can be the exit aperture to the main channel when the sleeve body is in closed configuration as stated in the above), wherein the second end is spaced apart from the first end of the sleeve body along a longitudinal axis of the sleeve body (when in closed configuration), wherein the sleeve body comprises a stretchable, breathable fabric (col. 4,lines 9-29, cotton, wool, fleece are stretchable and breathable fabric) configured to slide over a head and onto a neck of an animal (functional recitation to which the wrap device can and does perform the intended function, see col. 3, lines 45-67); and a sheath (26,58, or 136) coupled to and extending from the sleeve body, the sheath extending continuously and circumferentially around a second longitudinal axis to define a secondary channel (the second channel can be seen for the embodiments of ref. 58 or ref. 136), the sheath defining a third aperture on a first end of the secondary channel and a fourth aperture on a second end of the secondary channel (the apertures are at the ends of the sheath as shown for sheath 58 or sheath 136), wherein the second end of the secondary channel is spaced apart from the first end of the secondary channel along the second longitudinal axis of the sheath. In addition, as stated in col. 6, lines 5-14 of Hidalgo, the holder assembly or sheath can be position vertically, horizontally (shown in fig. 1), diagonally, etc. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the first longitudinal axis is substantially perpendicular to the second longitudinal axis as taught by Hidalgo in the device of Dula-White as modified by Shesol et al. and Denicola et al., depending on the user’s preference to place the sheath in a location or configuration that is easy to access, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
For claim 16, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, but is silent about wherein the sleeve body further comprises a cord stop configured to reduce a circumference of the first or second end of the sleeve body. In addition to the above, Hidalgo teaches the sleeve body further comprises a cord stop (col. 4, lines 30-44 of Hidalgo). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a cord stop as taught by Hidalgo on the sleeve body of Dula-White as modified by Shesol et al. and Denicola et al. in order to allow the user to further fasten the sleeve body around a body part of the user so as to hold the sleeve body and sheath better thereon.
For claim 17, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, but is silent about wherein the first end of the sleeve body comprises an elastic member configured to reduce a circumference of the first end of the sleeve body. In addition to the above, Hidalgo teaches the sleeve body further comprises an elastic member configured to reduce a circumference of the first end of the sleeve body (col. 4, lines 30-44 of Hidalgo). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include an elastic member configured to reduce a circumference of the first end of the sleeve body as taught by Hidalgo on the sleeve body of Dula-White as modified by Shesol et al. and Denicola et al. in order to allow the user to further fasten the sleeve body around a body part of the user so as to hold the sleeve body and sheath better thereon.
For claim 18, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, but is silent about wherein the sleeve body comprises a first portion adjacent to the first end of the main channel of the sleeve body and a second portion in between the first and second ends of the main channel of the sleeve body, wherein a first elasticity of the first portion is different than a second elasticity of the second portion. In addition to the above, Hidalgo teaches the sleeve body comprises a first portion adjacent to the first end of the main channel of the sleeve body and a second portion in between the first and second ends of the main channel of the sleeve body, wherein a first elasticity of the first portion is different than a second elasticity of the second portion (as stated in col. 4, lines 30-44 of Hidalgo, the user can use any combination of the coupling assembly 24 for the sleeve body, thus, one end can have a cord stop and the other end can have elastic strap which will result in the portions having different elasticity due to using different couplings). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the sleeve body of Dula-White as modified by Shesol et al. and Denicola et al. be comprised of a first portion adjacent to the first end of the main channel of the sleeve body and a second portion in between the first and second ends of the main channel of the sleeve body, wherein a first elasticity of the first portion is different than a second elasticity of the second portion as taught by Hidalgo in order to allow the user to further fasten the sleeve body around a body part of the user so as to hold the sleeve body and sheath better thereon.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Dula-White as modified by Shesol et al. and Denicola et al. as applied to claim 1 above, and further in view of Matusak (US 20120090558 A1).
For claim 15, Dula-White as modified by Shesol et al. and Denicola et al. teaches the device of claim 1, but are silent about wherein the sheath further comprises a cord stop configured to reduce a circumference of the first or second end of the sheath.
Matusak teaches a device comprising a sheath (34c) having a cord stop (the ties in drawstring 36a,b to stop the cord from displacement) configured to reduce a circumference of the first or second end of the sheath. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a cord stop as taught by Matusak in the sheath of Dula-White as modified by Shesol et al. and Denicola et al. in order to further secure the medical device onto the sheath.
Response to Arguments
Applicant’s arguments with respect to claims 1,2,5-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SON T NGUYEN whose telephone number is (571)272-6889. The examiner can normally be reached 9:00 to 4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Poon can be reached at 571-272-6891. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Son T Nguyen/Primary Examiner, Art Unit 3643
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