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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) submitted November 7, 2022 is/are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the double-walled needle having an inner wall and an outer wall of claim 5 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: reference number “119” assigned to “venting channel” on page 20, line 13.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 3, 6, 9, and 19 are objected to because of the following informalities:
Claim 3, line 2 recites “the venting aperture” which should be changed to “the elongated venting aperture” to be consistent with claim 1.
Claim 3, line 2 recites “the longitudinal direction” which lacks antecedent basis and should be changed to “a longitudinal direction”.
Claim 6, line 2 recites “the venting aperture” which should be changed to “the elongated venting aperture” to be consistent with claim 1.
Claim 9, lines 1-2 recite “the coupling” which lacks antecedent basis and should be changed to “a coupling”.
Claim 19, lines 2-3 refer to “an intrinsic velocity between 100 m3/kg and 500 m3/kg” and it appears the word “velocity” is a typo which should be “viscosity”. For the purpose of examination, the claim will be treated as referring to an “intrinsic viscosity”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a heating element for heating the injection fluid” in claim 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The generic term “element” is defined by the function of “heating” and is not defined by the structure capable of performing the function. Therefore, the “heating element” meets the requirements of 35 USC 112(f).
Upon inspection of the applicant’s specification, the specification fails to describe the structure of the “heating element”. At best, page 12, line 25 through page 13, line 12 describe the function of the “heating element” as “heating the injection fluid before the injection fluid is injected behind the tympanic membrane”. Further, the heating element can be located within the container or external to the container, or on a tube between the needle and container. At most the specification describes the function and location of the “heating element” but fails to describe the structure. None of the Figures are described as showing the heating element. Accordingly, rejections under 35 USC 112(a) and (b) will be put forth below (see MPEP §2181 II A for further clarification).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 15 is 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.
As stated above, claim 15 introduces “a heating element” which is interpreted under 35 USC 112(f). The specification fails to describe the structure of the heating element, and therefore it is unknown whether the inventor had possession of the claimed invention.
The applicant has not provided sufficient disclosure to show possession of the claimed invention. Under 35 USC 112(a), possession is shown by describing the claimed invention. Claim 15 contains subject matter which was not described in such a way as to reasonably convey that the inventor or joint inventors had possession of the claimed invention, and therefore claim 15 is rejected under 35 USC 112(a) for failing the written description requirement.
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 2, 14, 15, and 17-19 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.
Claim 2, line 2 introduces “at least two elongated venting apertures”, line 3 introduces “a first elongated venting aperture” and line 4 introduces “a second elongated venting aperture”. It is unclear whether the “first elongated venting aperture” and “second elongated venting aperture” are part of the “at least two elongated venting apertures” or are separate features. For the purpose of examination, they will be treated as being part of the “at least two elongated venting apertures”.
Claim 14, line 3 recites “the injection fluid preferably has an intrinsic viscosity between 100 m3/kg and 500 m3/kg” and the word “preferably” makes it unclear whether the limitation is required or not. For the purpose of examination, the claim will be treated as not requiring the limitation.
Claim 15, line 2 introduces “a heating element” which is interpreted under 35 USC 112(f) as explained above. The specification fails to describe the structure of the “heating element” which makes the scope of the claim unknown, which renders the claim indefinite.
Claim 17, lines 1-2 recite “the injection fluid” which lacks proper antecedent basis. Claim 17 depends from claim 1, however neither claim 1 nor claim 17 introduce “an injection fluid”. At most, claim 1 introduces “a fluid”. The examiner notes claim 16 introduces “an injection fluid” and thus, it is unclear whether the dependency of claim 17 is correct or not. For the purpose of examination, claim 17 will be treated as properly introducing “an injection fluid”.
Claim 18, lines 1-2 introduce “the pharmaceutical component” which lacks proper antecedent basis. Claim 18 depends from claim 1, however neither claim 1 nor claim 18 introduce “a pharmaceutical component”. The examiner notes claim 17 introduces “a pharmaceutical component”, and thus, it is unclear whether the dependency of claim 18 is correct or not. For the purpose of examination, claim 18 will be treated as properly introducing “a pharmaceutical component”.
Claim 19, lines 1-2 recite “the injection fluid” which lacks proper antecedent basis. Claim 19 depends from claim 1, however neither claim 1 nor claim 19 introduce “an injection fluid”. At most, claim 1 introduces “a fluid”. The examiner notes claim 16 introduces “an injection fluid” and thus, it is unclear whether the dependency of claim 19 is correct or not. For the purpose of examination, claim 19 will be treated as properly introducing “an injection fluid”.
Any and all claims rejected above under 35 USC 112(b), if rejected with art below under sections 35 USC 102 and/or 103, is/are rejected as best understood.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 4, 7, 10, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 6,024,726 to Hill.
In Reference to Claim 1#
Hill teaches:
A fluid injection device for injecting a fluid behind a tympanic membrane (50 in Figure 5) of a patient, comprising:
a hollow needle (42) having a needle tip (end of needle within the patient) with a fluid outlet (opening at end of needle tip) at a distal end (end of needle opposite attachment to fluid injection device) thereof, the needle tip being configured for piercing the tympanic membrane of the patient (see Figure 5);
a container (18) for storing the fluid to be injected behind the tympanic membrane, the container being arranged in fluid communication with the hollow needle;
wherein the hollow needle comprises an elongated venting aperture (48 in Figures 4 and 5) in an outer wall (outer surface of 42) thereof, the elongated venting aperture being positionable at an inner side of an ear membrane (the tympanic membrane 50 in Figure 5) of the patient as well as at an outer side of said ear membrane when injecting fluid, so as to allow excess fluid on the inner side of said membrane to flow through the elongated venting aperture, to the outer side of said membrane (see column 2, line 28 through column 3, line 42 and Figures 1, 2, 4, and 5).
Hill describes the purpose of the syringe assembly as for aspirating fluid from the middle ear (column 1, lines 7-9). Figure 5 shows the fluid within the middle ear being drawn into the needle tip to enter the container within the syringe. Figure 5 also shows fluid outside of the tympanic membrane is drawn into the middle ear through the membrane via the canal 48 in order to equalize the pressure when fluid is aspirated through the needle (column 3, lines 38-41). While Hill only describes the fluid moving in one direction, the syringe would be capable of operating in the opposite direction as well. Fluid within the container could be injected through the needle into the middle ear beyond the tympanic membrane. When injecting fluid, any excess fluid could still move out of the membrane by passing through the canal 48. Therefore, the examiner considers the syringe of Hill to be a fluid injection device and the canal to be an elongated venting aperture which can allow fluid to flow through the elongated venting aperture.
In Reference to Claim 3
Hill teaches:
The fluid injection device according to claim 1, wherein the elongated venting aperture is arranged in a longitudinal direction (left to right in Figure 5) of the needle.
In Reference to Claim 4
Hill teaches:
The fluid injection device according to claim 1, wherein the hollow needle is a single-walled needle (see Figure 5).
In Reference to Claim 7
Hill teaches:
The fluid injection device according to claim 1, further comprising a grip (housing 10 having needle hub 32 and anchoring means 34), releasably coupled to the hollow needle at a proximal end (end of the needle in anchoring means 34, see Figure 2) of the hollow needle, for holding the needle (column 2, line 63 through column 3, line 1). The user is capable of holding the fluid injection device by the body, and therefore the examiner considers the body to be a “grip”. The needle is coupled to the anchoring means 34, which is removable from the needle hub 32. Therefore, the grip is releasably coupled to the hollow needle.
In Reference to Claim 10
Hill teaches:
The fluid injection device according to claim 7, wherein the grip includes a display (walls of housing 10) arranged in communication with the container, the display being configured for displaying the amount of fluid injected with the fluid injection device. The housing is made of a translucent material, such as glass (column 2, lines 43-45), and therefore the amount of fluid is visible through the entire wall of the grip – including the display.
In Reference to Claim 13
Hill teaches:
A hollow needle (42) for use in a fluid injection device, the hollow needle having a needle tip (end of needle within the patient) with a fluid outlet (opening at end of needle tip) at a distal end (end of needle opposite attachment to fluid injection device) thereof, the needle tip being configured for piercing a tympanic membrane (50 in Figure 5) of the patient (see Figure 5); and
comprising an elongated venting aperture (48 in Figures 4 and 5) in an outer wall (outer surface of 42) thereof, the elongated venting aperture being positionable at an inner side of an ear membrane (the tympanic membrane 50 in Figure 5) of the patient as well as at an outer side of said ear membrane when injecting fluid, so as to allow excess fluid on the inner side of said membrane to flow through the elongated venting aperture, to the outer side of said membrane (see column 2, line 28 through column 3, line 42 and Figures 1, 2, 4, and 5).
Hill describes the purpose of the syringe assembly as for aspirating fluid from the middle ear (column 1, lines 7-9). Figure 5 shows the fluid within the middle ear being drawn into the needle tip to enter the container within the syringe. Figure 5 also shows fluid outside of the tympanic membrane is drawn into the middle ear through the membrane via the canal 48 in order to equalize the pressure when fluid is aspirated through the needle (column 3, lines 38-41). While Hill only describes the fluid moving in one direction, the syringe would be capable of operating in the opposite direction as well. Fluid within the container could be injected through the needle into the middle ear beyond the tympanic membrane. When injecting fluid, any excess fluid could still move out of the membrane by passing through the canal 48. Therefore, the examiner considers the needle of the syringe of Hill to be a hollow needle for use in a fluid injection device and the canal to be an elongated venting aperture which can allow fluid to flow through the elongated venting aperture.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claim(s) 2 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,024,726 to Hill as applied to claim 1 above, and further in view of US 9,937,300 to Beckstein.
In Reference to Claim 2
Hill teaches:
The fluid injection device according to claim 1, wherein the hollow needle comprises one elongated venting aperture.
Hill fails to teach:
The hollow needle comprises at least two elongated venting apertures, and wherein a distance between a first elongated venting aperture of the at least two elongated venting apertures and the fluid outlet differs from a distance between a second elongated venting aperture of the at least two elongated venting apertures and the fluid outlet.
Beckstein teaches:
A fluid injection device comprising a hollow tube (100) comprising at least two elongated venting apertures (both 214), and wherein a distance (not numbered, see annotated Figure 4) between a first elongated venting aperture (leftmost instance of 214 in Figure 4) of the at least two elongated venting apertures and a fluid outlet (212) differs from a distance (not numbered, see annotated Figure 4) between a second elongated venting aperture (adjacent instance of 214 in Figure 4) of the at least two elongated venting apertures and the fluid outlet (see column 4, lines 4-63 and Figures 1, 2, and 4).
Beckstein teaches the elongated venting apertures are designed to relieve fluid pressure at an injection site (column 4, lines 18-20). The elongated venting apertures can be located at a different radial angle relative to the circumference of the outer shaft 102 (column 4, lines 60-63). Figure 4 shows the elongated venting apertures are spaced along the outer shaft at different distances from the tip.
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid injection device of Hill by adding an elongated venting aperture to have at least two elongated venting apertures which are spaced different distances from the fluid outlet as taught by Beckstein as both references are directed to fluid injection devices having elongated venting apertures, and for the purpose of being able to further relieve pressure by being able to release fluid from multiple apertures at multiple distances.
In Reference to Claim 5
Hill teaches:
The fluid injection device according to claim 1 comprising the hollow needle.
Hill fails to teach:
The hollow needle is a double-walled needle having an inner wall and an outer wall, a fluid injection channel being defined by the inner wall and a venting channel being defined between the outer wall and the inner wall.
Beckstein teaches:
A fluid injection device having a double-walled tube (100) having an inner wall (108) and an outer wall (102), a fluid injection channel (lumen in inner shaft 108) being defined by the inner wall and a venting channel (lumen between shafts 102 and 108) being defined between the outer wall and the inner wall (see column 4, lines 4-17 and Figure 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid injection device of Hill by re-shaping the needle to be double-walled having an inner wall and an outer wall with respective channels as taught by Beckstein as both references are directed to fluid injection devices which relieve pressure by removing excess fluid, and which is a known technique for a known device which would yield predictable results. In this case, the predictable result would be a double-walled needle where the excess fluid which is removed from the middle ear is gathered in the venting channel.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,024,726 to Hill as applied to claim 1 above, and further in view of WO 2012/156959 to Vaughan et al.
In Reference to Claim 6
Hill teaches:
The fluid injection device according to claim 1 comprising the needle having the elongated venting aperture.
Hill fails to teach:
The needle, at or near an area of the elongated venting aperture, is arranged, comprises a positioning indicator for indicating a pre-defined insertion depth of the needle.
Vaughan teaches:
A fluid injection device (100) comprising a needle (140) having a positioning indicator (not shown, “graduation marking”, see page 3, lines 21-22) for indicating a pre-defined insertion depth of the needle.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid injection device of Hill by adding positioning indicators to the needle as taught by Vaughan as both references are directed to needles inserted into patients, and for the purpose of indicating the depth of how far the needle has been inserted into the patient.
When modifying the fluid injection device of Hill with the teachings of Vaughan, the positioning indicators would be added along the length of the needle, including at or near an area of the elongated venting apertures of Hill.
Claim(s) 8, 9, 11, 12, 14, 16-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,024,726 to Hill as applied to claim 1 above, and further in view of US 12,138,436 to Sacherman.
In Reference to Claim 8
Hill teaches:
The fluid injection assembly according to claim 7 having the container.
Hill fails to teach:
The fluid injection device further comprises a pump for pumping the fluid from the container into the hollow needle, wherein the grip comprises a touch button for activating the pump.
Sacherman teaches:
A fluid injection device (100) comprising a pump (pumping mechanism 410) for pumping fluid from a container (reservoir 120) into a hollow needle (needle assembly 115), wherein a grip (pistol grip for housing 105 having gripping features 127, see Figure 4A, column 10, lines 9-16) comprises a touch button (actuator 107) for activating the pump (see column 9, lines 41-56 and Figures 2C and 4A).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid injection device of Hill by adding a pump and re-shaping the grip to also include a touch button to active the pump as taught by Sacherman which is a simple substitution which yields predictable results. In this case, the predictable result would be a fluid injection device where a pump drives the fluid toward the patient when activated by the button rather than when a user manual pushes a plunger.
In Reference to Claim 9#
Hill as modified by Sacherman teaches:
The fluid injection device according to claim 8, comprising a coupling (anchoring means 34 of Hill) between the hollow needle and the grip.
Hill is silent regarding the coupling being of the rotational type to allow rotation of the grip withs respect to the hollow needle.
Sacherman teaches a coupling (canal guide 110) between the hollow needle and the grip, wherein the coupling being of the rotational type to allow rotation of the grip withs respect to the hollow needle (see column 11, lines 23-29, column 16, lines 55-65 and Figure 4K).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid injection device of Hill as modified by Sacherman by configuring the coupling to be the rotational type to allow rotation of the grip with respect to the hollow needle as taught by Sacherman for the purpose of being able to re-position the needle relative to the patient to select the most comfortable or convenient ergonomic positioning while still controlling the position of the needle assembly (column 17, lines 2-6 of Sacherman).
In Reference to Claim 11
Hill teaches:
The fluid injection assembly according to claim 7, comprising the grip.
Hill fails to teach:
The grip comprises two recesses for receiving, in use, a finger of a user, and a line of sight from an eye of a user using the fluid injection device into the ear canal of the patient is defined between the two recesses.
Sacherman teaches:
A fluid injection device comprising a grip comprising two recesses (grooves within gripping features 127 in Figure 19A) for receiving, in use, a finger of a user, and a line of sight from an eye of a user using the fluid injection device into the ear canal of the patient is defined between the two recesses (see column 23, lines 11-16 and Figure 19A). The user’s line of sight is through the viewing lens 143, which is between the gripping features 127, and therefore the line of sight from an eye of a user is between the two recesses.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid injection device of Hill by re-configuring the grip to add recesses for receiving fingers of a user, and a line of sight between the two recesses as taught by Sacherman for the purpose of allowing an ergonomical and comfortable configuration (column 23, lines 16-18 of Sacherman).
In Reference to Claim 12
Hill teaches:
The fluid injection assembly according to claim 1.
Hill fails to teach:
An endoscope that is rigidly connected to at least a proximal portion of the needle, the endoscope being arranged in communication with a screen, so as to provide a visual representation of the needle tip and its surroundings on the screen via the endoscope.
Sacherman teaches:
A fluid injection device comprising an endoscope (not shown, see column 21, line 34) that is rigidly connected to at least a proximal portion (section attached to canal guide 110) of a needle (115), the endoscope being arranged in communication with a screen (143), so as to provide a visual representation of the needle tip and its surroundings on the screen via the endoscope (see column 21, lines 6-39).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid injection device of Hill by adding an endoscope in communication with a screen as taught by Sacherman for the purpose of improving the safety of the device by allowing the user to view the tympanic membrane (column 21, lines 31-34 of Sacherman).
In Reference to Claim 14
Hill teaches:
An injection assembly comprising the fluid injection device according to claim 1.
Hill fails to teach:
An injection fluid.
Sacherman teaches:
An injection assembly comprising a fluid injection device (needle 115) and an injection fluid (material being delivered, see column 8, lines 20-23) which is injected behind the tympanic membrane (column 8, lines 46-51).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the injection assembly of Hill by adding an injection fluid as taught by Sacherman for the purpose of being able to treat middle ear disorders (column 8, lines 46-51 of Sacherman).
In Reference to Claims 16-18, and 20
Hill teaches:
The fluid injection device according to claim 1.
Hill fails to teach:
An injection fluid for use in preventing, alleviating or curing hearing loss, wherein the injection fluid comprises a pharmaceutical component, wherein a pharmaceutical component is sodium thiosulfate, and wherein the hearing loss is sensorineural hearing loss or is induced by a platinum-based drug.
Sacherman teaches:
A fluid injection device comprising an injection fluid (material being delivered, see column 8, lines 20-23) for use in preventing hearing loss which is sensorineural hearing loss (column 34, lines 55-61), wherein the injection fluid comprises a pharmaceutical component which is sodium thiosulfate (column 36, lines 3-5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid injection device of Hill by adding an injection fluid which comprises sodium thiosulfate as a pharmaceutical component as taught by Sacherman for the purpose of preventing sensorineural hearing loss.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,024,726 to Hill as modified by US 12,138,436 to Sacherman as applied to claim 14 above, and further in view of US 8,075,524 to Wang.
In Reference to Claim 15
Hill as modified by Sacherman teaches:
The fluid injection assembly of claim 14 comprising the fluid injection device and the injection fluid which is injected behind the tympanic membrane.
Hill as modified by Sacherman fails to teach:
The fluid injection device comprises a heating element for heating the injection fluid before the injection fluid is injected behind the tympanic membrane.
Wang teaches:
An injection assembly comprising a fluid injection device (syringe 500), an injection fluid (fluid contained in the syringe), and a heating element (heating device 100) for heating the injection fluid before the injection fluid is injected (see column 2, lines 22-24 and Figure 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the injection assembly of Hill as modified by Sacherman by adding a heating element as taught by Wang as both references are directed to fluid injection assemblies, and for the purpose of warming the fluid to reduce patient discomfort by reducing temperature mismatch (column 1, lines 24-31 of Wang).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,024,726 to Hill as applied to claim 1 above, and further in view of US 12,138,436 to Sacherman and case law.
In Reference to Claim 19
Hill teaches:
The fluid injection device according to claim 1.
Hill fails to teach:
An injection fluid, wherein the injection fluid has an intrinsic viscosity between 100 m3/kg and 500 m3/kg.
Sacherman teaches:
A fluid injection device comprising an injection fluid (material being delivered, see column 8, lines 20-23) for use in preventing hearing loss. The injection fluid inherently has an intrinsic viscosity.
The Court has held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP §2144.05 II A for further clarification). In In re Aller, a claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be obvious over a prior art process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.
In the instant application, Hill as modified by Sacherman teaches a fluid injection device having an injection fluid which can include sodium thiosulfate as a therapeutic agent (column 36, lines 3-5 of Sacherman). This injection fluid inherently has an intrinsic viscosity, however Sacherman is silent regarding the value.
The examiner notes page 13, lines 21-27 of the applicant’s specification state the injection fluid preferably has an intrinsic viscosity between 100 m3/kg and 500 m3/kg, preferably comprises a pharmaceutical component, and preferably the pharmaceutical component is sodium thiosulfate. The applicant has not shown any criticality for the claimed range.
There is a reasonable expectation of success because modifying the injection fluid to have an intrinsic viscosity between 100 m3/kg and 500 m3/kg would still allow the fluid to be injected by the fluid injection device and enter the middle ear of the patient to treat the disorder. Further, the composition of the injection fluid of Sacherman matches the composition described by the applicant.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid injection device of Hill by adding an injection fluid as taught by Sacherman for the purpose of being able to deliver medication to a patient.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid injection device of Hill as modified by Sacherman by designing the injection fluid with an intrinsic viscosity between 100 m3/kg and 500 m3/kg in view of case law for the purpose of being able to effectively treat hearing loss in a patient by delivering the medication via the fluid injection device. The injection fluid would have an intrinsic viscosity and viscosity which allows it to be injected into the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 9,132,087 to Lichter et al teaches an injection fluid comprising sodium thiosulfate treats hearing loss and the viscosity is designed to “provide an optimal rate of release from a otic compatible gel” (column 126, lines 45-47). US 7,351,246 to Epley teaches a fluid injection device comprising a plurality of venting apertures. US 2008/0262468 to Clifford teaches a fluid injection device comprising vent tubes which allow air to escape to prevent excessive pressure.
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/JASON G DAVIS/Examiner, Art Unit 3745
/NATHANIEL E WIEHE/Supervisory Patent Examiner, Art Unit 3745