DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The disclosure is objected to because of the following informalities:
The amendment filed 17 April 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure [“The present application is a filing under 35 U.S.C. 371 as the National Stage of International Application No. PCT/FR2022/052036, filed October 26, 2022, entitled ‘OCULAR SUCTION DEVICE,’ which claims priority to French Application No. 2111359 filed with the Intellectual Property Office of France on October 26, 2021, both of which are incorporated herein by reference in their entirety for all purposes.” (emphasis applied by the Examiner)]. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: incorporation(s) by reference to foreign priority document(s) when added by amendment at the time of entry to the national stage is/are considered new matter [An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)) (MPEP § 608.01(p)(I)(B)); An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application (MPEP § 1893.03(b))]]. Applicant is required to cancel the new matter in the reply to this Office Action.
Appropriate correction is required.
Claim Objections
Claim(s) 1, 7-8, and 10 is/are objected to because of the following informalities:
Claim 1 should read “[[the]] a mucosa of an animal” [lines 1-2].
Claim 1 should read “[[the]] a top of the distal surface” [line 6].
The Examiner notes that claim 1, 7-8, and 10 recite either of “airtight enclosure” and “sealed enclosure” interchangeably. The Examiner notes that each instance of either “airtight enclosure” and “sealed enclosure” should be amended to only recite one of “airtight enclosure” or “sealed enclosure” for consistency purposes.
Claim 10 should read “[[the]] a length of the perforation system emerging from the reservoir is less than [[the]] a maximum height of the sealed enclosure” [lines 2-3].
Appropriate correction is required.
Claim Interpretation
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “magnification means” in claim(s) 8, which fails to be further limited by any limitation reciting the magnification means performing a specified function.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1, 5-6, 8, and those dependent therefrom is/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 1 recites the limitation “a collection system consisting of a tube joined to the top of the distal surface of the sealed enclosure, inside which a reservoir slides that is passed through by a perforation system oriented toward the mucosa, opposite the opening” [lines 6-8], which is considered indefinite, as the Examiner notes that the transitional phrase “consisting of…” excludes any element, step, or ingredient not specified in the claim [see MPEP § 2111.03(II)], wherein additional disclosure of the Applicant’s Specification and Drawings render the use of “consisting of…” unclear, as the Applicant’s disclosure defines additional elements that may comprise the collection system [the Examiner notes that the Applicant’s specification recites "A collection means may consist of a tube joined to the top of the enclosure, inside which a reservoir with a needle passing through it can slide", wherein the use of ‘may’ is considered to render the following limitation as being exemplary, wherein the Examiner notes that the embodiments of the invention as disclosed and depicted by the Applicant fail to explicitly disclose or depict a structure that only consists of the elements as claimed; see Figs. 2A-B, which depict an “active vacuum for generating suction bubble” and “active vacuum 1 (“sealing” and securing the conjunctiva” as passing through the collection system, which are considered to be additional elements of the collection system; see 2nd and 3rd stage of the collection system as depicted in Fig. 4 and described on p. 12-13 of the Specification which define at least a “sliding sealed slat, crossed at its center by the arm coming from the reservoir”, which is considered to be an additional element of the collection system], such that it is unclear whether the Applicant has intended to use the transitional phrase “consisting of…” or not. For examination purposes, the Examiner has interpreted the transitional phrase “consisting of…” to instead recite “comprising”.
Claim 1 recites the limitation “the walls of the sealed enclosure are hollow” [line 9], wherein the Examiner notes that “the walls” lacks antecedent basis, as the enclosure was not previously defined as comprising a plurality of walls and may merely be defined by a single continuous wall.
Claim 1 recites the limitation “wherein the walls of the sealed enclosure are hollow, and optionally connected to a second suction system” [lines 9-10], which is considered indefinite, as it is not clear whether the emphasized portion wherein the walls of the sealed enclosure are connected to a second suction is meant to be included or not, as the Examiner notes that the use of “optionally…” is considered to be exemplary claim language [MPEP § 2173.05(d)]. For examination purposes, the Examiner has interpreted the optional limitation to not be required based on any prior art applied under § 102 or § 103.
Claim 5 recites the limitation “wherein the opening in the proximal surface of the enclosure has an area of between 3 and 350 mm2, and is optionally adjustable” [lines 2-3], which is considered indefinite, as it is not clear whether the emphasized portion wherein the opening in the proximal surface of the enclosure is optionally adjustable is meant to be included or not, as the Examiner notes that the use of “optionally…” is considered to be exemplary claim language [MPEP § 2173.05(d)]. For examination purposes, the Examiner has interpreted the optional limitation to not be required based on any prior art applied under § 102 or § 103.
Claim 6 recites the limitation “the suction system” [line 2], which is considered indefinite, as claim 1 defines “a first suction system” [line 5] and an optional “second suction system” [line 10], such that it is unclear whether the indefinite limitation of claim 6 is meant to refer to the first suction system, the optional second suction system, or both the first and optional second suction systems. For examination purposes, the Examiner has interpreted any of the identified interpretations to be applicable in light of any prior art applied under § 102 or § 103.
Claim 8 recites the limitation “wherein the sealed enclosure has transparent surfaces, and optionally a magnification means on the top of its distal surface” [lines 2-3], which is considered indefinite, as it is not clear whether the emphasized portion of a magnification means on the top of its distal surface is meant to be included or not, as the Examiner notes that the use of “optionally…” is considered to be exemplary claim language [MPEP § 2173.05(d)]. For examination purposes, the Examiner has interpreted the optional limitation to not be required based on any prior art applied under § 102 or § 103.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 1 and those dependent therefrom is/are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites the limitation “an airtight enclosure whose proximal surface in direct contact with the mucosa has an opening” [lines 3-4], which is considered to positively recite the human body [see emphasized portion]. The Examiner suggests amending the limitation to read “an airtight enclosure whose proximal surface is configured to be in direct contact with the mucosa has an opening” to recite a function of the device instead of the human body.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1-7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krasnow (US-10765361-B2) in view of Andino (US-20170095369-A1), as evidenced by Subileau (“Lymphatics in Eye Fluid Homeostasis: Minor Contributors or Significant Actors?”, NPL attached), and Kromer (EP-3542765-A1, translation attached).
Regarding claim 1, Krasnow teaches
A device for collecting a sample of fluid from tissue of an animal for analysis, said device comprising:
(i) an airtight enclosure whose proximal surface in direct contact with the tissue has an opening defining a collection area, and whose distal surface comprises at least one port connected to a first suction system [The seal 143 includes a concave depression 123 through which the hollow needle 120 penetrates the seal 143 to form a hole in the seal 143 when driven downward by the piston 130. A channel 145 is formed above the concave depression 123 behind the seal 143 and connecting the region behind the seal 143 with an evacuated volume 141 formed in the housing 110… Atmospheric gases are prevented from entering the evacuated volume 143 through the chamber 131 by the sealant layer 139 and prevented from entering the evacuated volume 141 through the bottom of the housing 110 (e.g., through the concave depression 123) by the seal 143 (Krasnow Col 10:34-40, 41-46, Fig. 1B); The device 100 could additionally include a conformal layer configured to conform to the skin such that suction applied by the evacuated volume 141 (or by some other suction source of the device 100) through one or more holes in the seal 143 (or by some other means, e.g., through the needle channel 125) is applied to skin proximate the one or more holes in the seal 143 (Krasnow Col 10:66-11:5), wherein the housing 110 is considered to define a distal surface of the enclosure (see Annotated Fig. 1), which is coupled via channel 145 to evacuated volume 141; and wherein the opening is considered to be defined by the hole formed in the seal 143 by needle 120, and as the vacuum is applied to skin, the enclosure is considered to be airtight even as the needle 120 forms a hole in seal 143], and
(ii) a system consisting of [see corresponding § 112(b) rejection and interpretation above] a tube joined to the top of the distal surface of the sealed enclosure [wherein chamber 131 as depicted in Krasnow Figs. 1A-B is considered to define a tube joined to the top of the distal surface of the enclosure (defined by the housing 110)], inside which a reservoir slides that is passed through by a perforation system oriented toward the tissue, opposite the opening [A piston 130 is coupled to the needle 120 and configured to slidably move within the chamber 131 (e.g., along the long axis of the chamber 131). A reservoir 150 containing a payload 155 (for example, a drug-containing fluid, gel, or hydrogel) is formed in the piston 130 and coupled to the needle channel 125 within the hollow needle 120 (Krasnow Col 9:48-54, Fig. 1B)].
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Annotated Fig. 1. Krasnow Fig. 1B has been annotated to identify the claimed enclosure, wherein the enclosure as identified in the device 100 of Krasnow is considered to be an airtight enclosure [enclosed by housing 110 and sealant layer 139]
However, Krasnow fails to explicitly disclose wherein the system defined in (ii) is a collection system. Krasnow does disclose that different elements of the device (100) may define a collection chamber for fluid drawn from the tissue, including at least the needle channel (125) [Other elements of the device 100 (e.g., the channel 145, the concave depression 123, the hole formed in the bottom of the chamber 131, the needle channel 125, or some other elements of the device 100 could act as a collection chamber for blood drawn from skin by a suction source and/or received by the device 100 by some other means (Krasnow Col 10:59-65)], wherein Krasnow explicitly discloses and depicts the needle channel (125) as being fluidically coupled to and extending into a proximal end of the reservoir (150) as defined by the piston (130) [Krasnow Col 9:48-54, Fig. 1B].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krasnow to employ the reservoir (150) as a collection reservoir to define a collection system, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [MPEP § 2143(I)(D)].
However, Krasnow fails to explicitly disclose wherein the device is for collecting a sample of interstitial fluid from the mucosa of an animal, wherein the proximal surface of the airtight enclosure is in direct contact with the mucosa.
Andino discloses systems for collecting a sample of a fluid from a body tissue, wherein Andino discloses that the system may be employed to collect a sample of blood from a body tissue or the conjunctiva of an eye of a subject [While the embodiments have been described above in use on ocular tissue, in some instances, the embodiments and methods described herein can be used on any other suitable bodily tissue. For example, in some instances, the use of an adjustable length needle can be beneficial in conjunction with standard phlebotomy techniques during drug infusion and/or blood draw from a vein. Thus, while the embodiments and methods are specifically described above in use on ocular tissue, it should be understood that the embodiments and methods have been presented by way of example only, and not limitation (Andino ¶0144); In some embodiments, the target tissue is an eye and the target surface is the conjunctiva of the eye (Andino ¶0034); The embodiments and methods described herein can be used to treat, deliver substances to and/or aspirate substances from, various target tissues in the eye. For reference, FIGS. 1-4 are a various views of a human eye 10 (with FIGS. 2-4 being cross-sectional views). While specific regions are identified, those skilled in the art will recognize that the proceeding identified regions do not constitute the entirety of the eye 10, rather the identified regions are presented as a simplified example suitable for the discussion of the embodiments herein (Andino ¶0047)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krasnow to employ the device for collecting a sample of interstitial fluid from the mucosa of an animal, wherein the proximal surface of the airtight enclosure is in direct contact with the mucosa, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [MPEP § 2143(I)(D)].
However, while Andino discloses that those skilled in the art would recognize that the aspiration of substances from at least the conjunctiva is non-limiting [Andino ¶0047], Krasnow in view of Andino fails to explicitly disclose that the substance that may be aspirated from the mucosa [conjunctiva] is interstitial fluid. Subileau discloses that the conjunctiva is known to contain lymphatic vessels containing interstitial fluid [The lymphatic vasculature has been recognized to be a key actor in several physiological processes and in many human diseases. Among its functions, the lymphatic vascular system exerts a major role in the regulation of interstitial fluid homeostasis. In addition to the exchanges between plasma and extracellular fluids by the blood vascular system, the lymphatics drain the excess of interstitial fluids that are not returned directly back to the blood capillaries (Subileau p. 1); Lymphatic vessels are present in the corneolimbus bordering the avascular cornea, and in both bulbar and palpebral conjunctiva (Subileau p. 4, Fig. 4)], such that substances aspirated from the conjunctiva may be considered to include interstitial fluid.
However, while Krasnow discloses that the sealed enclosure of the device may be mounted onto tissue for sampling [The device 100 could additionally include a conformal layer configured to conform to the skin such that suction applied by the evacuated volume 141 (or by some other suction source of the device 100) through one or more holes in the seal 143 (or by some other means, e.g., through the needle channel 125) is applied to skin proximate the one or more holes in the seal 143. Such a conformal layer could include polyurethane, soft rubber, polymeric gel, or some other compliant material. Additionally or alternatively, such a conformal layer could include a glue (e.g., cyanoacrylate), a tape, a dry adhesive, or some other adhesive substance (Krasnow Col 10:66-11:5), wherein the optional conformal layer would be considered to define at least a portion of the sealed enclosure], Krasnow in view of Andino, as evidenced by Subileau, fails to explicitly disclose wherein the walls of the sealed enclosure are hollow, and optionally connected to a second suction system.
Kromer discloses systems for drug delivery into an eye of a subject, wherein Kromer discloses a housing configured to be in contact with the conjunctiva of the eye, wherein the housing defines an enclosure with hollow walls connected to a suction system [The housing 7 further comprises a vacuum chamber 14, which is opened via an opening 24 to the distal end 10 of the housing 7 such that a negative pressure generated in the vacuum chamber 14 sucks the contact surface 12 of the housing 7 to the conjunctiva of the eye (Kromer p. 5)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krasnow in view of Andino, as evidenced by Subileau, to employ wherein the walls of the sealed enclosure are hollow, and optionally connected to a second suction system, so as to allow for application and adherence of the device onto the conjunctiva of a subject for sampling.
Regarding claim 2, Krasnow in view of Andino, as evidenced by Subileau, and Kromer teaches
The device according to claim 1, where the mucosa is the conjunctiva [see § 103 modification of claim 1 above; Andino ¶0047].
Regarding claim 3, Krasnow in view of Andino, as evidenced by Subileau, and Kromer teaches
The device according to claim 1, wherein the proximal surface of the enclosure is domed [see Annotated Fig. 1].
Regarding claim 4, Krasnow in view of Andino, as evidenced by Subileau, and Kromer teaches
The device according to claim 1, wherein the proximal surface of the enclosure is covered by a flexible seal [seal 143 (Krasnow Col 10:37-40, 41-46, Fig. 1B)].
Regarding claim 5, Krasnow in view of Andino, as evidenced by Subileau, and Kromer teaches
The device according to claim 1.
However, Krasnow fails to explicitly disclose wherein the opening in the proximal surface of the enclosure has an area of between 3 and 350 mm2, and is optionally adjustable.
Krasnow does disclose that the area of the opening in the proximal surface of the enclosure is a result effective variable that may affect the amount of fluid to be collected [The diameter (or gauge) of the hollow needle 120 could be specified to maximize the amount of blood emitted from skin and/or to minimize discomfort induced by piercing of skin by the hollow needle 120. For example, the hollow needle 120 could have a gauge between approximately 21 gauge and approximately 36 gauge (Krasnow Col 11:46-51), wherein a 21 G needle 120 is considered to define at least a 2.11 mm2 hole in seal 143]. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Krasnow in view of Andino, as evidenced by Subileau, and Kromer to have an opening within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krasnow in view of Andino, as evidenced by Subileau, and Kromer to employ wherein the opening in the proximal surface of the enclosure has an area of between 3 and 350 mm2 as a matter of routine optimization since it has been 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 optimization.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 6, Krasnow in view of Andino, as evidenced by Subileau, and Kromer teaches
The device according to claim 1.
However, while Krasnow discloses wherein the suction system creates a vacuum of less than 375 mmHg [The evacuated volume 141 could have a pressure less than approximately 50 kilopascals (Krasnow Col 10:57-59)], Krasnow in view of Andino, as evidenced by Subileau, and Kromer fails to explicitly disclose wherein the suction system creates a vacuum of less than 300 mmHg.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vacuum created by the suction system of Krasnow in view of Andino, as evidenced by Subileau, and Kromer from being less than 375 mmHg to being less than 300 mmHg since it I has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Applicant appears to have placed no criticality on the claimed range [see Applicant’s Specification p. 9:21-23, 11:5-6, wherein the Applicant notes that the vacuum created as exemplary].
Regarding claim 7, Krasnow in view of Andino, as evidenced by Subileau, and Kromer teaches
The device according to claim 1, wherein the distal surface of the sealed enclosure is covered at least on its top with a material that can be pierced by the perforation system and closes over the latter when pierced to maintain the seal [sealant layer 139 (Krasnow Col 10:37-40, 41-46, Fig. 1B); Krasnow Col 10:66-11:5, wherein the housing 110 maintaining a vacuum seal while applied to tissue and while the needle 120 is actuated is considered to read on the sealant layer maintaining closure over perforation system when pierced].
Regarding claim 9, Krasnow in view of Andino, as evidenced by Subileau, and Kromer teaches
The device according to claim 1, wherein the reservoir has a capacity ranging from 10 to 300 μl [Blood accessed using devices and methods disclosed herein could be used for a variety of applications. Such applications could include any applications where one or more properties of a person and/or of blood of the person can be detected or determined from a volume of blood accessed using such devices. The volume of blood can be related to the configuration of the device, and could be between approximately one and approximately 10 microliters. For example, the device could be configured to access (e.g., to penetrate the skin and to apply suction to the skin to draw) more than approximately 3 microliters of blood and to detect the concentration of one or more analytes (e.g., glucose, hormones, blood cells) in the accessed blood (Krasnow Col 9:3-15), wherein based on the § 103 modification above, the reservoir has been modified to collect interstitial fluid, but is still understood to have a capacity as defined by Krasnow].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krasnow in view of Andino, as evidenced by Subileau, and Kromer, as applied to claim 1 above, in further view of Smith (US-20130338612-A1).
Regarding claim 8, Krasnow in view of Andino, as evidenced by Subileau, and Kromer teaches
The device according to claim 1.
However, Krasnow in view of Andino, as evidenced by Subileau, and Kromer fails to explicitly disclose wherein the sealed enclosure has transparent surfaces, and optionally a magnification means on the top of its distal surface.
Smith discloses systems for intraocular injection, wherein Smith discloses that the portion of the system that is configured to interface with a subject’s eye is transparent [Those of skill in the art will understand that the foot 105 (or a portion thereof) may be made from a transparent material such that alignment with a periphery of the cornea may be facilitated (Smith ¶0039)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krasnow in view of Andino, as evidenced by Subileau, and Kromer to employ wherein the sealed enclosure has transparent surfaces, so as to allow for viewing of the subject’s eye during a procedure using the device to facilitate alignment of the device for operation.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krasnow in view of Andino, as evidenced by Subileau, and Kromer, as applied to claim 1, in further view of Kochamba (US-20040092875-A1).
Regarding claim 10, Krasnow in view of Andino, as evidenced by Subileau, and Kromer teaches
The device according to claim 1.
However, Krasnow in view of Andino, as evidenced by Subileau, and Kromer fails to explicitly disclose wherein the length of the perforation system emerging from the reservoir is less than the maximum height of the sealed enclosure.
Kochamba discloses a system for injecting a tissue, wherein Kochamba depicts a length of a needle extending into an enclosure configured to contact tissue, wherein the length of the needle that extends into the enclosure is less than a maximum height of the enclosure [The area 34 is for receiving the surface 38 of the cutaneous layer 28 about which the proximal end 36 of the needle 26 is to pierce to effect an injection of fluid 32. The area 34 includes a surface 40, the surface being for receiving the cutaneous layer 28 under action of the suction force, and thereby stabilize the cutaneous layer prior to and during piercing of the cutaneous layer by the proximal end 36 of the needle 26 (Kochamba ¶0049, Figs. 1-4), wherein as depicted in Figs. 1-4, the needle 26 does not extend beyond the maximum height of area 34; It also assists in achieving a consistent depth of needle penetration to avoid damage to other body structures such as tendons, nerves and bones (Kochamba ¶0092)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krasnow in view of Andino, as evidenced by Subileau, and Kromer to employ wherein the length of the perforation system emerging from the reservoir is less than the maximum height of the sealed enclosure, so as to prevent the perforation system from extending beyond a controlled depth.
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791