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 § 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 1,5-13,19-23 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 collar for an animal that has hair (the sleeve in Dula-White is a collar based on the definition of a collar; also, the collar in Dula-White is for a medical patient, which patient can be human or animal because Dula-White did not specifically stated human alone; also, a human is an animal that has hair, thus, even considering a human as a patient, the human would meet the definition of an animal that has hair), the collar configured to retain an implanted medical device protruding from a neck of the animal (functional recitation to which the collar of Dula-White can perform the intended function of configured to retain an implanted medical device protruding from a neck of the animal), the collar 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 the neck of the 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 that may adhere to the hair of the animal (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 would not adhere to the hair); 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 configured to receive and retain an esophagostomy tube, 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 devoid of hook and loop fasteners that may adhere to the hair of the animal.
Denicola et al. teach in the same field of endeavor of a collar 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) 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), 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 devoid of hook and loop fasteners that may adhere to the hair of the animal (sheath 40 is attached by sewing as shown in fig. 1, thus, it is not hook and loop fasteners that may adhere to the hair of the animal). 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 collar 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 collar 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 collar 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 collar 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 collar 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 collar of claim 1, and further teaches wherein the collar is devoid of fasteners that may adhere to the hair of the animal (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, col. 5, lines 1-8 of Dula-White states that one can use other fasteners instead of hook and loop fasteners, thus, would be devoid of hook and loop fasteners and would not adhere to the hair).
For claim 11, Dula-White as modified by Shesol et al. and Denicola et al. teaches the collar 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 collar 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 collar 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), wherein, in the access configuration, the esophagostomy tube maybe inserted into or removed from the sheath and a surgical site maybe inspected and cleaned (functional recitation to which a user can insert or remove the esophagostomy tube as desired).
For claim 19, Dula-White as modified by Shesol et al. and Denicola et al. teaches the collar 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 an esophagostomy tube implanted on a neck (Shesol et al. teach the tube on the neck in fig. 9) of an animal that has hair (as explained in the above with Dula-White), the method comprising:
providing the retaining device as explained in the above claim 1 (as explained in the above claim 1);
placing the collar 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 esophagostomy tube 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 collar of claim 1, and further teach wherein the sleeve body is devoid of fasteners that may adhere to the hair of the animal (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 would not adhere to the hair).
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 esophagostomy tube on the neck of the animal (Dula-White teaches inspecting and cleaning per col. 2, lines 55-60, col. 3, lines 10-17, col. 6, lines 38-44, thus, as combined with Shesol and Denicola, it would result in inspecting or cleaning the site of the esophagostomy tube on the neck of the animal); 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).
For claim 23, Dula-White as modified by Shesol et al. and Denicola et al. teaches the limitation as claimed, even with “consisting essentially of” as explained in the above. Although “consisting essentially of” is a middle ground between “comprising” and “consisting of”, all elements as claimed are taught by the prior art and any additional elements do not materially affect the basic and novel characteristics of the claimed invention. No other additional elements were relied on with the prior art that would impact the claimed invention. Thus, Dula-White as modified by Shesol et al. and Denicola et al. teaches “consisting essentially of”.
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 collar 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 collar 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 collar 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 collar 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 collar 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 collar 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 filed 8/13/2026 have been fully considered but they are not persuasive. Applicant argued the following:
In this case, the preamble supplies the antecedent basis for "an animal" recited throughout claim 1. Furthermore, the preamble is relied upon throughout the body of the claim to breathe life and meaning into the limitations, rather than merely stating intended use. Therefore, the terms in the preamble should be construed as substantive claim limitations.
While applicant amended the preamble to state “an animal”, this does not overcome the prior art of rejection because “an animal” can include a human, which “supposedly” Dula-White is alleged to teach but he never stated human in the specification. In addition, an animal that has hair clearly reads on a human more than a dog because conventionally known, dogs have fur more than hair. However, some dogs might have hair but still, the guaranteed animal that has hair is a human so the preamble actually reads on more for human than “dog” or other animals that may have furs. Thus, applicant’s preamble does not “breathe life and meaning” into the limitations because the preamble recites more of a human than a dog because all human has hair but not all dog has hair. Furthermore, the body of the claim does not further limit the preamble because the body of the claim calls for general sleeve body, a sheath, etc. and nothing specific to a dog only or a human only.
Dula-White is directed to human patients (e.g., those undergoing dialysis or cancer treatment) and neither discloses nor suggests a device configured for use with a hair-bearing animal. Thus, the sleeve of Dula-White cannot be considered a "collar for an animal" such as the dog shown in FIG. 2C of the present application. For at least this reason, Dula-White fails to disclose each and every feature of claim 1 including, at least, "a collar for an animal that has hair."
Nowhere in Dula-White did she disclose a human patient as stated by applicant. Dula-White broadly stated “patient” and did not limit to human only. Even assuming Dula-White meant for human, it is still within the scope of the claimed invention of an animal that has hair.
In addition, while applicant shows a dog, para. 0003 stated that the living subject is not limited to dogs, cats, guinea pigs, sheep, goats, horses, pigs, cows, or ruminants. It is clear that the collar of the claimed invention can be worn by a human too if the user wishes to do so because the structure of the collar is not limited to a dog. It is just a collar with no special structure(s) that would lead one skill in the art to say that the collar is made specially only for a dog and cannot be placed on a human.
Like Dula-White, Shesol is directed to a human patient - not a hair-bearing animal. Therefore, securing device of Shesol cannot be considered a "collar for an animal" such as the dog shown in FIG. 2C of the present application. For at least this reason, Shesol also fails to disclose each and every feature of claim 1 including, at least, "a collar for an animal that has hair."
As stated in the above, a human is an animal that has hair, thus, it is clear that Shesol teaches the functionally claimed limitation. In addition, as stated in the rejection, Shesol was only relied on if applicant disagrees with Dula-White but Dula-White already teaches the claimed limitation. In another word, the claimed limitation is merely functional to which Dula-White’s collar can be use for the neck because it has the structure to be used around the neck. However, Shesol was relied on for added or secondary proof/evidence that a collar can be used around a neck of an animal.
Additionally, Denicola generally teaches a "garment for shielding from an infant's head and hands, intravenous and gastrostomy lines." Denicola, Abstract. Because Denicola is directed to a garment for a human infant (not an animal having hair), the garment of Denicola cannot be considered a "collar for an animal" such as the dog shown in FIG. 2C of the present application. For at least this reason, Denicola also fails to disclose each and every feature of claim 1 including, at least, "a collar for an animal that has hair."
As stated in the above, a human is an animal that has hair, thus, it is clear that Denicola et al. teach the functionally claimed limitation. In addition, Denicola et al. were not relied on for a teaching of a collar. Denicola et al. were relied on for the sheath as clearly stated in the rejection.
On page 6 of the Office Action, the Examiner cites a section of Dula-White that states "[t]wo or more edges of a sleeve may be joined by thread, glue, staple, snaps, hooks, zippers, any combinations thereof." Dula-White Col. 5, In. 6-8. However, this passage describes how the edges of the Dula-White sleeve are joined during manufacture. It says nothing about how the sleeve's construction affects its use to retain a wound care component. By contrast, the claimed "devoid of hook and loop fasteners" limitations (including the sleeve body and the sheath) concern the collar's structure and its effects on securing the collar to the animal and retaining the medical device.
Applicant’s invention is a sleeve with edges that are joined together by thread at the stitched line shown clearly in fig. 3. Dula-White teaches a sleeve that are joined together at the edges by thread or other equivalent fasteners. Thus, it is clear that Dula-White teaches the claimed limitation. Hook and loop fasteners as mentioned in Dula-White is NOT required to be used; it is an option in addition to other types of fasteners. Thus, the user can select thread for stitching the edges of the sleeve, which means that the sleeve body will be devoid of hook and loop fasteners.
In addition, applicant’s comment of “However, this passage describes how the edges of the Dula-White sleeve are joined during manufacture. It says nothing about how the sleeve's construction affects its use to retain a wound care component” is unclear because this has nothing to do with the structure of the sleeve and is not relevant to what is being claimed.
Furthermore, the claimed limitation stated, “that may adhere to the hair”, which is not a positively or guarantee condition that the hook and loop fasteners WILL. What if the hook and loop does not? Thus, to say that this added limitation has structure, it does not, it is merely conditional, meaning it could adhere hair but then it could not.
Lastly, even if hook and loop fasteners were to be used in Dula-White, the hook and loop fastened to each other and close up the edges of the sleeve so there is a good chance that hair will not be adhered because the hook and loop surfaces are not exposed in open air or surface.
As shown in FIGS. 1 and 2 of Dula-White, the sleeve 100 includes a "sleeve interior 200" that includes a "fastener 212" that "may include any variation of reusable adhesive such as snaps, Velcro, reusable adhesive film, magnets, or any combination thereof." Dula-White at Col. 5, In. 38-40. For example, the fastener 212 may include two components: one component "attached to sleeve interior 200" and one component "attached to a wound care component." Id. at Col. 5, In. 42-47. Then, "[w]hen applying a sleeve to a patient, the wound care component may be attached to a sleeve interior using fastener 212." Id. at Col. 5, In. 48-50. Thus, Dula-White expressly identifies hook and loop fasteners, along with similar adherable fasteners, in contrast with the limitations of claim 1.
Similar to the above comment, Dula-White did NOT require hook and loop fasteners to be used. Dula-White listed options of fasteners so one skill in the art can select other fasteners such as adhesive film, magnets, etc. that are not hook and loop fasteners.
Therefore, Shesol fails to teach each and every feature of amended claim 1, such as "wherein the sleeve body is devoid of hook and loop fasteners that may adhere to the hair of the animal" or "wherein the sheath is devoid of hook and loop fasteners that may adhere to the hair of the animal." For at least this additional reason, amended claim 1 is patentable over the cited references.
The examiner did not rely on Shesol for fasteners, let alone hook and loop fasteners; thus, applicant’s argument is mooted.
Shesol was relied on for the concept of using a sleeve body on a neck of an animal such as a human in fig. 9, 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”.
Therefore, Denicola fails to teach each and every feature of amended claim 1, such as "wherein the sleeve body is devoid of hook and loop fasteners that may adhere to the hair of the animal" or "wherein the sheath is devoid of hook and loop fasteners that may adhere to the hair of the animal." For at least this additional, independent reason, Denicola fails to disclose or suggest either "devoid of hook and loop fasteners" limitation of amended claim 1.
The examiner did not rely on Denicola for fasteners, let alone hook and loop fasteners; thus, applicant’s argument is mooted.
In addition, Denicola et al. employ stitching and not hook and loop fasteners for the sheath as relied on in the rejection and shown in Denicola’s fig. 1.
Instead of forming a prima facie case of obviousness, the Examiner has taken a piecemeal approach with respect to the claim language. In particular, the Examiner has examined each prior art reference in isolation, rather than considering how they would work together from the perspective of a skilled person. This segmented analysis fails to consider a motivation to combine the disclosures to arrive at the claimed invention.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The examiner has clearly articulated rationale for combining the references as required for obviousness. As stated, Shesol et al. were relied on for the concept of using a collar around a neck of an animal so one skill in the art would use the collar of Dula-White on a neck of an animal as taught by Shesol et al., if it happens that the neck is the site for the injury. In addition, using the collar around the neck is functional recitation as long as the structure can perform the intended function, which in this case, Dula-White’s collar can. Adding Shesol et al. were merely to further stating that using a collar around a neck of an animal is nothing new and it is functional.
As for Denicola et al., as stated, Denicola et al. were relied on for the sheath with the features as stated above, 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. Dula-White teaches that one can attach a wound care component with fastener 212 so relying on the same concept with a more specific features from Denicola et al. does not make Dula-White’s collar inoperable as stated by applicant. As a matter of fact, the combination would improve Dula-White’s collar for better operability and would work the same as intended to hold a wound care component.
The Examiner's alleged rationale is conclusory and reflects impermissible hindsight. The Examiner's stated reason for the combination is "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." This reasoning is a hypothetical contingency, not a problem or need identified in Dula-White, Denicola, or other cited references.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
First, the claimed limitation is nothing more than a functional recitation of the sheath being able to be configured to receive and retain an esophagostomy tube, which the sheath as modified with Denicola et al. can perform this function.
Second, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, although Dula-White and Denicola et al. did not directly state functional recitation of “esophagostomy tube”, one can considered using such tube because the sheath as modified with Denicola et al. to Dula-White can hold the esophagostomy tube if the user wishes to do so since the sheath is designed to hold a tube. The motivation to combine is not hypothetical contingency, but taught from the teaching of the references themselves.
Combining the sleeve of Dula-White with the tabs or anchoring devices of Denicola would result in a device that (a) fails to adequately apply a wound care component and/or (b) fails to adequately hold a tube in place. For example, if the tabs of Denicola were added to the interior of the Dula-White sleeve (e.g., in place of the fastener, as proposed by the Examiner), the resulting device could no longer adhere to or retain a wound care device. In particular, the tab could not apply gauze to hold ointment in place or absorb blood, as required by the sleeve of Dula-White. Alternatively, the tab could only secure a tube at a single point, unlike the claimed sheath. In situations where the wearer is highly active or mobile (e.g., a dog wearing the claimed collar), securing the tube with a singular tab on the inside is likely insufficient and presents a risk becoming pulled loose.
The examiner respectfully disagrees because adding the sheath as taught by Denicola et al. would allow the user to attach a wound care component in the form of a tube inside the collar. The sheath of Denicola et al. would be able to hold a gauze because it is a sheath so the user would just place the gauze inside the sheath. As far as adequate or not, that is up to the user’s careful placement and not the capability of the sheath being able to hold a gauze or not.
As to applicant’s comment (b), Denicola’s sheath is designed to hold a tube such as a catheter so why would it fail adequately to hold a tube in place? Applicant’s argument about a single point is irrelevant because this is not even being claimed and it is it not clear what is a single point or multiple point? It is merely a sheath that allows a user to attach a tube for treatment, simple as that. A risk becoming pulled loose depends on the user and not on the collar because if the user is aggressive, nothing will stay in place, even the collar itself. Thus, to argue with an entity that has nothing to do with the structure of the collar and has more to do with the user would be irrelevant.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Son T Nguyen/ Primary Examiner, Art Unit 3643
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