DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 9 June 2026. The Examiner acknowledges the amendments to claims 1, 5, 8, and 10, and the addition of claims 11-15. Claims 1-15 are pending.
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 is incorporated herein by reference in its entirety for all purposes. This application also claims priority to French Application No. 2111359 filed with the Intellectual Property Office of France on October 26, 2021.” (emphasis applied by 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) 7-8 and 12 is/are objected to because of the following informalities:
Claim 7 should read “wherein the distal surface of the sealed enclosure is covered at least on [[its]] the top of the distal surface” [lines 1-2].
Claim 8 should read “wherein the sealed enclosure has transparent surfaces on the top of [[its]] the distal surface of the sealed enclosure” [lines 2-3].
Claim 12 should read “wherein the sealed enclosure has a magnification means on top of [[its]] the distal surface of the sealed enclosure” [lines 1-2].
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) 12.
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, 6, 12, 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 “the walls of the sealed enclosure are hollow” [line 11], 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 6 recites the limitation “the suction system” [line 2], which is considered indefinite, as claim 1 defines “a first suction system” [lines 5-6] and “a second suction system” [line 12], such that it is unclear whether the indefinite limitation of claim 6 is meant to refer to the first suction system, the second suction system, or both the first and 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 12 recites the limitation “wherein the sealed enclosure has a magnification means on top of its distal surface”, which is considered indefinite, as claim 8 previously recites “wherein the sealed enclosure has transparent surfaces on the top of its distal surface” [lines 1-3], such that it is unclear whether the recited magnification means of claim 12 is meant to further limit the transparent surfaces as defined in claim 8 to at least partially comprise the transparent surfaces or not. For examination purposes, the Examiner has interpreted either identified interpretation to be applicable in light of any applied art under § 102 or § 103.
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, 9-11, and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krasnow (US-10765361-B2, previously presented) in view of Andino (US-20170095369-A1, previously presented) [as evidenced by Subileau (“Lymphatics in Eye Fluid Homeostasis: Minor Contributors or Significant Actors?”, NPL previously attached)], Kromer (EP-3542765-A1, translation previously attached), and Kochamba (US-20040092875-A1, previously presented).
Regarding claim 1, Krasnow teaches
A device for collecting a sample of fluid from a tissue of an animal for analysis, said device comprising:
(i) a sealed enclosure whose proximal surface is configured to be in direct contact with the tissue has an opening defining a collection area, and whose distal surface comprises at least one port connect 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 comprising a tube joined to a 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)].
wherein the walls of the sealed enclosure are hollow and connected to a second suction system, wherein the second suction system is configured to secure the enclosure against the mucosa, and wherein the first suction system is configured to subsequently apply a vacuum to the collection system to form a suction bubble of interstitial fluid from the mucosa.
PNG
media_image1.png
275
479
media_image1.png
Greyscale
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 sealed 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 a mucosa of an animal, wherein the proximal surface of the sealed 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)].
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], 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.
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 a mucosa of an animal, wherein the proximal surface of the sealed 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 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], and that use of the device comprises ordered steps of securing the enclosure against tissue [or mucosa based on the modification in view of Andino (as evidenced by Subileau) above] prior to sample collection [The pressure in the evacuated volume 141 is sufficiently lower than the pressure of the environment surrounding the device 100 that, when one or more holes are formed in the seal 143 by the hollow needle 120, the evacuated volume 141 acts as a suction source to draw blood from skin, through the one or more holes in the seal 143 (Krasnow Col 10:47-53)], Krasnow in view of Andino [as evidenced by Subileau] fails to explicitly disclose wherein the walls of the sealed enclosure are hollow, and connected to a second suction system, wherein the second suction system is configured to secure the enclosure against the mucosa, and wherein the first suction system is configured to subsequently apply a vacuum to the collection 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)]. Kromer further discloses performing ordered steps in which the suction system of the enclosure of the housing is configured to secure the enclosure against the conjunctiva, and wherein a needle is subsequently used to penetrate the conjunctiva [The contact surface 12 is then placed on the conjunctiva 19 of an eye 20 and positioned on the conjunctiva 19 on the basis of its outer contour 21, 21 '… Since the contact surface 12 rests airtight on the conjunctiva 19, but no or hardly any air can flow into the vacuum chamber 14, so that in the vacuum chamber 14, a negative pressure. The contact surface 12 sucks and thus the device 2 to the conjunctiva 19 fixed… The tip 3 is now inserted into the receptacle 11 of the housing 7 in such a way that the injection needle 5 pierces the film 17 and the injection needle 5 penetrates into the conjunctiva 19 of the eye 20 through the passage opening 16 and through the opening 24 surrounded by the abutment surface 12 (Kromer p. 22-23)].
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 connected to a second suction system, wherein the second suction system is configured to secure the enclosure against the mucosa, and wherein the first suction system is configured to subsequently apply a vacuum to the collection system, so as to allow for application and adherence of the device onto the conjunctiva of a subject prior to application of the first suction system for sampling.
However, Krasnow in view of Andino [as evidenced by Subileau] and Kromer fail to teach or suggest wherein the application of the vacuum to the collection system by the first suction system is to form a suction bubble of interstitial fluid from the mucosa.
Kochamba discloses systems for injecting tissue, wherein Kochamba discloses applying a vacuum to tissue to form a suction bubble of the tissue [A self-administering system with the device and method of the invention is particularly advantageous. This could be for emergency use, for instance for administering a shot for something like anthrax vaccine. A patient who is self-administering a drug or the like could be nervous and the skin could be shaking which would otherwise cause problems. The vacuum or suction stabilizes the tissue and this stabilizes the device relative to the tissue to prevent any sideways movement of the needle, which may otherwise damage the skin. 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, Fig. 1), wherein the tissue as depicted in Kochamba Fig. 1 is considered to form a “bubble” based on the plain definition of “bubble” referring to a small globule that is typically hollow and light: such as something (such as a plastic or inflatable structure) that is hemispherical or semicylindrical (https://www.merriam-webster.com/dictionary/bubble)].
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 application of the vacuum to the collection system by the first suction system is to form a suction bubble of interstitial fluid from the mucosa, as forming a bubble is considered to facilitate sample collection by stabilizing the tissue and device relative to the tissue.
Regarding claim 2, Krasnow in view of Andino [as evidenced by Subileau], Kromer, and Kochamba 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], Kromer, and Kochamba 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], Kromer, and Kochamba 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], Kromer, and Kochamba teaches
The device according to claim 1.
However, Krasnow in view of Andino [as evidenced by Subileau], Kromer, and Kochamba fails to explicitly disclose wherein the opening in the proximal surface of the enclosure has an area of between 3 and 350 mm2.
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], Kromer, and Kochamba 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], Kromer, and Kochamba 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], Kromer, and Kochamba 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], Kromer, and Kochamba 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], Kromer, and Kochamba 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], Kromer, and Kochamba 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].
Regarding claim 10, Krasnow in view of Andino [as evidenced by Subileau], Kromer, and Kochamba teaches
The device according to claim 1.
However, Krasnow in view of Andino [as evidenced by Subileau], Kromer, and Kochamba as presently modified fails to explicitly disclose wherein a length of the perforation system emerging from the reservoir is less than a maximum height of the sealed enclosure.
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], Kromer, and Kochamba to employ wherein a length of the perforation system emerging from the reservoir is less than a maximum height of the sealed enclosure, so as to prevent the perforation system from extending beyond a controlled depth.
Regarding claim 11, Krasnow in view of Andino [as evidenced by Subileau], Kromer, and Kochamba teaches
The device according to claim 5, wherein the opening in the proximal surface of the enclosure is adjustable [The diameter (or gauge) of the needle 120 could be specified to maximize the amount of blood emitted from the skin 105 and/or to minimize discomfort induced by piercing of the skin 105 by the needle 120. For example, the needle 120 could have a gauge between approximately 21 gauge and approximately 36 gauge (Krasnow Col 10:43-49), wherein as the needle gauge is adjustable (changed depending on specifications) and the size of the needle determines the size of the opening (Krasnow Col 10:66-11:5, see interpretation of Krasnow regarding the opening in claim 1 above), the opening is considered to be adjustable, as different sizes of needles may be employed to define different sizes of the opening].
Regarding claim 13, Krasnow in view of Andino [as evidenced by Subileau], Kromer, and Kochamba teaches
A method of collecting a sample of interstitial fluid from a mucosa of an animal using the device of claim 1, comprising:
placing the proximal surface of the sealed enclosure in direct contact with the mucosa [See § 103 modification of claim 1 above; Krasnow Col 10:66-11:5; Andino ¶0034; Kromer p. 5];
activating the second suction system to apply a vacuum to the walls of the sealed enclosure to secure the enclosure against the mucosa [See § 103 modification of claim 1 above; Kromer p. 5, 22-23]; and
subsequently activating the first suction system to apply a vacuum to the collection system to form a suction bubble of interstitial fluid from the mucosa [See § 103 modification of claim 1 above; Kromer p. 22-23; Kochamba ¶0092, Fig. 1].
Regarding claim 14, Krasnow in view of Andino [as evidenced by Subileau], Kromer, and Kochamba teaches
The method of claim 13, further comprising: advancing the perforation system through the reservoir and toward the suction bubble to perforate the mucosa, thereby drawing interstitial fluid into the reservoir [See § 103 modification of claim 1 above; Krasnow Col 9:48-54, 10:59-65, Fig. 1B; Kochamba ¶0092, Fig. 1].
Regarding claim 15, Krasnow in view of Andino [as evidenced by Subileau], Kromer, and Kochamba teaches
The method of claim 14, wherein activating the second suction system precedes activating the first suction system by an interval sufficient to establish a stable seal between the enclosure and the mucosa prior to formation of the suction bubble [See § 103 modification of claim 1 above; Kromer p. 22-23].
Claim(s) 8 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krasnow in view of Andino [as evidenced by Subileau], Kromer, and Kochamba, as applied to claim 8 above, in further view of Juhn (US-4766886-A).
Regarding claim 12 [written in longhand format to incorporate the subject matter of claim 8 therein], Krasnow in view of Andino [as evidenced by Subileau], Kromer, and Kochamba teaches
The device according to claim 1.
However, Krasnow in view of Andino [as evidenced by Subileau], Kromer, and Kochamba fails to explicitly disclose wherein the sealed enclosure has transparent surfaces on top of its distal surface, and wherein the sealed enclosure has a magnification means on the top of its distal surface [wherein based on the § 112(b) rejection and corresponding interpretation above, the magnification means are interpreted to further limit the claimed transparent surfaces].
Juhn discloses sample collection systems, wherein Juhn discloses positioning a magnification means on top of an enclosure configured to couple to a collection device [A convex lens 29 is retained in holder 28. Lens 29, as shown in FIG. 4, is in axial and optical alignment with opening 21. The focal point 32 of lens 29, as shown in FIG. 4, is adjacent the outside of open end 21 of ear piece 16. Lens 29 enables the examiner's eye 31 to visually inspect the tissue at focal point 32. Lens 29 enlarges the image of the tympanic membrane and identifies middle ear fluid at focal point 32. Lens 29 can be a lens assembly having a plurality of optical lenses. Lens holder 28 and lens 29 are axially spaced from the body 11 to allow fluid collectors, hereinafter described, to collect a sample of the middle ear fluid located at focal point 32 (Juhn Col 3:55-67, Figs. 1-4)].
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], Kromer, and Kochamba to employ wherein the sealed enclosure has transparent surfaces on top of its distal surface, and wherein the sealed enclosure has a magnification means on the top of its distal surface, so as to facilitate sample collection by enabling enhanced visual inspection of a tissue or sample.
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 8-11, filed 9 June 2026, with respect to the rejection(s) of claim(s) 1 and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Krasnow (US-10765361-B2, previously presented) in view of Andino (US-20170095369-A1, previously presented) [as evidenced by Subileau (“Lymphatics in Eye Fluid Homeostasis: Minor Contributors or Significant Actors?”, NPL previously attached)], Kromer (EP-3542765-A1, translation previously attached), and Kochamba (US-20040092875-A1, previously presented).
The Applicant asserts that Krasnow, Andino, Subileau, and Kromer do not teach or suggest, “wherein the second suction system is configured to secure the enclosure against the mucosa, and wherein the first suction system is configured to subsequently apply a vacuum to the collection system to form a suction bubble of interstitial fluid from the mucosa” as recited in claim 1, wherein the Applicant notes that neither Krasnow nor Kromer, alone or in combination, discloses or suggests wherein the device of amended claim 1 employs two distinct suction systems having distinct and sequential functions: (1) the second suction system, connected to the hollow walls of the enclosure, is configured to seal and secure the enclosure against the mucosa, creating a stable surface; and (2) the first suction system is configured to subsequently apply a vacuum to the collection system to form a suction bubble of interstitial fluid from the mucosa, from which the fluid sample is then extracted by the perforation system. Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Krasnow (US-10765361-B2, previously presented) in view of Andino (US-20170095369-A1, previously presented) [as evidenced by Subileau (“Lymphatics in Eye Fluid Homeostasis: Minor Contributors or Significant Actors?”, NPL previously attached)] and Kromer (EP-3542765-A1, translation previously attached) is further modified by Kochamba (US-20040092875-A1, previously presented), wherein the Examiner notes that Kochamba is considered to disclose applying a vacuum to tissue to form a suction bubble of the tissue [A self-administering system with the device and method of the invention is particularly advantageous. This could be for emergency use, for instance for administering a shot for something like anthrax vaccine. A patient who is self-administering a drug or the like could be nervous and the skin could be shaking which would otherwise cause problems. The vacuum or suction stabilizes the tissue and this stabilizes the device relative to the tissue to prevent any sideways movement of the needle, which may otherwise damage the skin. 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, Fig. 1), wherein the tissue as depicted in Kochamba Fig. 1 is considered to form a “bubble” based on the plain definition of “bubble” referring to a small globule that is typically hollow and light: such as something (such as a plastic or inflatable structure) that is hemispherical or semicylindrical (https://www.merriam-webster.com/dictionary/bubble)]. Furthermore, the sequential operation of the second suction and subsequently the first suction system is considered to be suggested by Krasnow and Kromer, as each of Krasnow and Kromer disclose securing the device to tissue prior to actuation of sample collection [The pressure in the evacuated volume 141 is sufficiently lower than the pressure of the environment surrounding the device 100 that, when one or more holes are formed in the seal 143 by the hollow needle 120, the evacuated volume 141 acts as a suction source to draw blood from skin, through the one or more holes in the seal 143 (Krasnow Col 10:47-53); The contact surface 12 is then placed on the conjunctiva 19 of an eye 20 and positioned on the conjunctiva 19 on the basis of its outer contour 21, 21 '… Since the contact surface 12 rests airtight on the conjunctiva 19, but no or hardly any air can flow into the vacuum chamber 14, so that in the vacuum chamber 14, a negative pressure. The contact surface 12 sucks and thus the device 2 to the conjunctiva 19 fixed… The tip 3 is now inserted into the receptacle 11 of the housing 7 in such a way that the injection needle 5 pierces the film 17 and the injection needle 5 penetrates into the conjunctiva 19 of the eye 20 through the passage opening 16 and through the opening 24 surrounded by the abutment surface 12 (Kromer p. 22-23)].
Applicant's arguments, see Applicant’s Remarks p. 11, with respect to the previously presented Specification Objection(s) have been fully considered but they are not persuasive.
The Examiner notes that the incorporation by reference of the French Application is what is considered to be new matter.
Applicant’s arguments, see Applicant’s Remarks p. 11, with respect to the previously presented claim objections have been fully considered and are persuasive. The objections to claims 1, 7-8, and 10 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 11, with respect to the previously applied rejection of claim 1 and those dependent therefrom under § 101 have been fully considered and are persuasive. The rejection of claim 1 and those dependent therefrom under § 101 has been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 12, with respect to the previously presented rejections under § 112(b) have been fully considered but they are not entirely persuasive.
Not all of the previously applied § 112(b) rejections were particularly addressed by the Applicant’s amendments. See above for maintained rejections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
Prosecution Insights