DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim(s) 12 and 14 is objected to because of the following informalities:
change claim 12 accordingly (to be consistent with claims 10-11): “the [[ultra-thin-walled]] ultrathin-walled microneedle”
change claim 14 accordingly: “barrel further comprises an”
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show whether the claimed “finger flanges” in claims 15-16 are the same as the “finger grip” shown figs. 3-5 and 7 and whether the claimed “finger grip” in the instant drawings is one or two finger flanges or grips as described in the specification (par. 76 recites “In some variations, the syringe has barrel flanges. In some variations, the syringe has finger grips” and par. 20 recites “finger flanges to provide grip to the user”). Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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 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.
Claims 3, 11, 13, 16, 19 and 20 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 3 recites “a cross-sectional area of said thumb press”. It is unclear if the claim 3 area (1) refers to the claim 1 line 8 “area” or (2) is a different area. For purposes of compact prosecution the claim is interpreted regarding the former.
Claim 11 recites “an ultrathin-walled microneedle”. It is unclear if the claim 11 microneedle refers to (1) refers to the claim 8 needle or (2) is a different needle. For purposes of compact prosecution the claim is interpreted regarding the former (par. 78, top appears to refer to both as the same needle).
Claim 11 recites “wherein an ultrathin-walled microneedle has an inner diameter greater than 250um”. The metes and bounds of the instant phrase is unclear because wherein an ultrathin-walled microneedle has an inner diameter greater than 250um the claim does not specify whether the microneedle is a part of the prefilled syringe or not. Thus it is not clear if the prefilled syringe is required to have the instant microneedle in order to infringe the claim. In contrast, claim 10 recites “further comprising an ultrathin-walled microneedle …”. For purposes of compact prosecution the claim is interpreted as the prefilled syringe having the claimed microneedle.
Claim 13 recites the limitation "said hydrogel solution" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "said finger flanges" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the hydrogel solution" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the hydrogel solution" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims dependent thereon are rejected for the same reasons.
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) 1-3, 6, 13 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0186740 A1 (Lewis) as evidenced by WO 2019/138019 A2 (Ryan), in view of US 20110034684 A1 (Yokokawa) and US 2020/0338270 A1 (Petrides).
Regarding claim 1, Lewis discloses (see fig. 1) a pre-filled (injectable hydrogels may be stored in and injected from barrels of medical devices such as syringes; see pars. 26, see “injectable hydrogels”, and 58; par. 24 discusses dispensing a drug from a “barrel” of syringes; par. 22 points out that syringes may be used to inject “non-drug” materials; further par. 26 discusses other medical devices with “barrels” are used to inject “non-drug” materials such as “hydrogels”; thus it is thought that one of ordinary skill would understand that the Lewis syringe dispenses a hydrogel, or in the alternative is capable of injecting hydrogel; that syringes are capable of injecting hydrogels is evidenced by Yokokawa par. 90 discussing “hyaluronic acid” hydrogel being injected from a syringe, hyaluronic acid being a hydrogel being consistent with applicant par. 38, bottom and applicant claim 6) syringe (see fig. 1) comprising: a syringe barrel (see “coated barrel” in fig. 1); a plunger comprising a plunger tip (see annotated figure below), a plunger rod (see annotated figure below), and a thumb press (see annotated figure below); and a sterile pharmaceutical composition (the hydrogel is for medical injection into “patients”, see pars. 21 and 26, and thus one of ordinary skill would understand such hydrogels to be a sterile pharmaceutical composition; this is evidenced by Ryan claims 29-30) comprising a hydrogel (see par. 26; one of ordinary skill would understand that the hydrogel of barrel of par. 26 applies to the barrel of instant syringe; this is evidenced by Ryan claims 29-30) wherein an internal diameter of a syringe barrel is less than 4mm (see par. 58: 2 mm); and a cross-sectional area (the cross-sect. area of thumb press that extends into and out of page) of said thumb press (see annotated figure below); an internal cross-sectional area (the internal cross-sect. area of barrel that extends into and out of page) of said syringe barrel (see annotated figure below). Lewis does not disclose a concentration of at least 10% w/w (or w/v) and a pharmaceutically acceptable carrier having a storage modulus C' of at least 160 Pa; and the cross-sectional area of said Lewis thumb press is at least 8-fold greater than the internal cross-sectional area of said Lewis Syringe barrel.
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[AltContent: textbox (plunger rod)][AltContent: arrow][AltContent: textbox (thumb press)][AltContent: arrow][AltContent: textbox (plunger tip)][AltContent: arrow][AltContent: textbox (needle)][AltContent: arrow][AltContent: textbox (inside surface)][AltContent: arrow]
Yokokawa teaches a syringe (see par. 90, bottom) and further teaches a (sterilized; see par. 69, bottom) hydrogel (see par. 29, top: “hyaluronic acid”; this is consistent with applicant par. 38, bottom) concentration of at least 10% w/w (or w/v) (see par. 29) and a pharmaceutically acceptable carrier (see hydrochloric acid and sodium hydroxide in par. 34; this is consistent with applicant par. 86, top) having a storage modulus C' of at least 160 Pa (see par. 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Lewis with a concentration of at least 10% w/w (or w/v) and a pharmaceutically acceptable carrier having a storage modulus C' of at least 160 Pa as taught by Yokokawa in order to facilitate improved biocompatibility and biodegradability regarding hydrogel hyaluronic acid for medical use (see Yokokawa par. 5).
Petrides teaches a syringe (see par. 49) and further teaches in combination with Lewis in view of Yokokawa a cross-sectional area of a thumb press is at least 8-fold greater than an internal cross-sectional area of a syringe barrel. Petrides teaches an example of a standard plunger flange with a diameter of about 19.13 mm (see par. 49) (see plunger flange 4 in fig. 1). It is further noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 at 1395 (U.S. 2007) (MPEP 2143 I.B.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute the cross-sectional area of the thumb press of Petrides for the cross-sectional area of the thumb press of Lewis in view of Yokokawa for the purpose of substituting one known element for another in order to provide the expected result of providing a user compression surface of the combination and to facilitate proven design wherein one of ordinary skill in the art understands that a larger surface area results in more stable ergonomic thumb rest (see pertinent prior art infra) and a thumb rest that can accommodate an increased force (see pertinent prior art infra) required of the user or patient regarding hydrogels. This results in the cross-sectional area of the thumb press of Lewis in view of Yokokawa and Petrides being = πr2 = π(
19.13
2
)2 = 287.4 mm. The cross-sectional area of the Lewis inner diameter is πr2 = π(
2
2
)2 = 3.14 mm. Thus area of the thumb press is about 90-fold greater than the area of the inner diameter of the barrel.
Regarding claim 2, Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. Lewis further discloses wherein a diameter of the plunger tip (see annotated figure above) is less than 4mm. The inner diameter of the barrel is 2mm and thus the claim 2 is met.
Regarding claim 3, The combination of Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. The combination teaches wherein a cross-sectional area of said thumb press (see annotated figure above) is at least 8-fold greater than a cross-sectional area of the plunger tip (see annotated figure above). This is so for the same reasons regarding the inner diameter of the barrel in the claim 1 analysis above.
Regarding claim 6, The combination of Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. The combination teaches wherein said hydrogel is hyaluronic acid (see Yokokawa par. 29, top: “hyaluronic acid”; this is consistent with applicant par. 38, bottom).
Regarding claim 13, The combination of Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. The combination teaches wherein said hydrogel solution has a storage modulus G' of at least 200 Pa (see Yokokawa par. 29).
Regarding claim 15, Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. Lewis does not disclose said syringe barrel further comprises finger flanges.
Petrides teaches (see annotated figure below) finger flanges (first and second finger flanges corresponding with barrel flange 6; it can be seen in fig. 6C that different fingers grip the two different finger flanges; this interpretation appears to be consistent with applicant fig. 4 showing a one piece “finger grip” wherein such structure is discussed as “finger grips” at par. 76, top). Please see drawing objection above and second rejection of claims 15-16 below regarding plural finger flange prior art Barry.
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[AltContent: textbox (first finger flange)][AltContent: arrow][AltContent: arrow][AltContent: textbox (second finger flange)]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Lewis in view of Yokokawa and Petrides with finger flanges as taught by Petrides in order to facilitate enabling user to manually control the syringe (see Petrides fig. 6C).
Regarding claim 16, The combination of Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. The combination teaches wherein said finger flanges resist a force greater than needed to eject said hydrogel. The force needed to eject hydrogel varies on how fast the ejection is, the density of the hydrogel and the size of the outlet of the syringe, and further varies regarding the initial force to start the ejection and a continuing force to keep the plunger in motion (see Lewis par. 4, bottom). Thus the finger flange at least resists a force greater than a force for a low acceleration or speed, or regarding the continuous force. It is noted that “resist a force greater than needed to eject said hydrogel” is intended use and the prior art need only be capable of performing the intended use.
Regarding claim 17, The combination of Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. The combination teaches wherein the cross-sectional area of said thumb press (see annotated figure above) is at least 10-fold greater than a cross-sectional area of said plunger tip (see annotated figure above). The value of 90-fold was determined in the claim 1 analysis above regarding the inside diameter of the barrel. Thus at least this instant value applies to the plunger tip.
Regarding claim 18, The combination of Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. The combination teaches wherein the cross-sectional area of said thumb press (see annotated figure above) is at least 15-fold greater than a cross-sectional area of said plunger tip (see annotated figure above). The value of 90-fold was determined in the claim 1 analysis above regarding the inside diameter of the barrel. Thus at least this instant value applies to the plunger tip.
Regarding claim 19, The combination of Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. The combination teaches wherein the hydrogel solution contains a biologically active substance (see Yokokawa par. 31: “1,2,7,8-diepoxyoctane” for example; this is consistent with applicant par. 62).
Regarding claim 20, The combination of Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. The combination teaches wherein the hydrogel solution is crosslinked (see Yokokawa par. 23).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis as evidenced by Ryan, in view of Yokokawa and Petrides as applied to claim 1 above, and further in view of US 3332764 (Knox).
Regarding claim 4, Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. Lewis discloses said syringe barrel is comprised of a material selected from glass (see par. 3, top) or a cyclic-olefin copolymer. Lewis does not disclose borosilicate glass.
Knox teaches a syringe and further teaches syringe barrel comprises borosilicate glass (see col. 4, ll. 65-66).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Lewis in view of Yokokawa and Petrides with borosilicate glass as taught by Knox in order facilitate using a type of glass that is commonly used for syringes and thus presents less risk (see Knox col. 4, ll. 65-66).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis as evidenced by Ryan, in view of Yokokawa and Petrides as applied to claim 1 above, and further in view of US 20120003497 A1 (Handy).
Regarding claim 5, Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. Lewis discloses wherein an inside surface (see annotated figure above) of said syringe barrel comprise a lubricant (see par. 54, top regarding coating on inside surface; see abstract regarding the coating being a lubricant). Lewis does not disclose covalently attached.
Handy teaches chemical vapor deposition of PTFE lubricant (this is consistent with Lewis; see pars. 8 and 34) onto inside surface of syringe by way of covalently attached (see claim 20 and pars. 4, 124).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Lewis in view of Yokokawa and Petrides with covalently attached in order to facilitate improving the lubricant deposition process (see Handy abstract).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis as evidenced by Ryan, in view of Yokokawa and Petrides as applied to claim 1 above, and further in view of US 2009/0155362 A1 (Longin).
Regarding claims 7-9, Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. Lewis discloses where a pressure necessary to eject (see par. 4 bottom) said hydrogel through a needle (see annotated figure above). Lewis does not disclose (claim 7) below 20N, (claim 8) below 15N and (claim 9) below 12N.
Longin teaches a syringe (see par. 6) for hyaluronic acid hydrogel (see par. 44) and further teaches a pressure necessary to eject said hydrogel through a needle (see claim 58) (claim 7) below 20N, (claim 8) below 15N and (claim 9) below 12N. The force of the New hydrogel is below 12.5 Newtons for most of the time duration in in fig. 4 wherein the Force increments on the Force vertical axis are 2.5 Newtons; see par. 42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Lewis in view of Yokokawa and Petrides with (claim 7) below 20N, (claim 8) below 15N and (claim 9) below 12N as taught by Longin in order to facilitate an easier injection effort by the used thus accommodating various medical conditions (see Longin par. 104). An alternative analysis is shown below in the scenario hydrogel of Longin is substantially different than that of Longin.
The presence of a known result-effective variable would be a motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. See KSR; MPEP 2144.05(II)(B). A particular parameter is a result-effective variable when the variable is known to achieve a recognized result. See In re Antonie, 559 F.2d 618, 620, 195 USPQ 6,8 (CCPA 1977).
Here, Longin teaches in paragraph 104 that a force or pressure necessary to eject a hydrogel such as hyaluronic acid through a needle controls how easy the hydrogel is able to be injected by the operator or patient. For example, the force can vary depending factors such as the type of hydrogel, the volume of the syringe, the size of the needle, the distance the plunger traverses and the speed and time of the ejecting action (see claim 58). A lower force having to be executed by the operator obviates the need for example motorized ejector that may not be available and is more expensive than a manually operated syringe. This is represented by Longin fig. 4 showing the lower force of the Longin hydrogel with syringe compared to the prior art. Therefore, an ordinary skilled worker would recognize that the force necessary to eject a hydrogel through a needle is a result-effective variable that controls the “syringeability” (see par. 5) of the hydrogel and the ability of the operator to complete the ejection thereof. Thus, the claimed (claim 7) wherein the pressure is below 20N, (claim 8) wherein the pressure is below 15N and (claim 9) wherein the pressure is below 12N is found to be an obvious optimization of the prior art obtainable by an ordinary skilled worker through routine experimentation.
Therefore, since the general conditions of the claim, i.e. a pressure necessary to eject said hydrogel through a needle, were disclosed in the prior art by Lewis in view of Yokokawa and Petrides, it is not inventive to discover the optimum workable range by routine experimentation, and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lewis in view of Yokokawa and Petrides’s invention to include wherein the pressure is below 20N, wherein the pressure is below 15N and wherein the pressure is below 12N in order to provide a syringe with hydrogel ejection easier to control by the operator as suggested and taught by Longin (see pars. 5, 6 and 104; claim 58; and fig. 4). It has been held “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).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis as evidenced by Ryan, in view of Yokokawa and Petrides as applied to claim 1 above, and further in view of US 20170296701 A1 (Young).
Regarding claims 10-12, Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. Lewis does not disclose (claim 10) an ultrathin-walled microneedle attached thereto; (claim 11) wherein an ultrathin-walled microneedle has an inner diameter greater than 250μm; and (claim 12) wherein the ultra-thin-walled microneedle has an outer diameter of less than 670μm.
Young teaches (see abstract and par. 18) a syringe for use with hyaluronic acid hydrogel and further teaches (see par. 18, middle) (claim 10) an ultrathin-walled microneedle attached thereto; (claim 11) wherein an ultrathin1-walled microneedle has an inner diameter greater than 250μm; and (claim 12) wherein the ultrathin-walled microneedle has an outer diameter of less than 670μm. Young’s needle (i.e., outer diameters of between 750 and 450 microns, and inner diameters between 450 and 240 microns) meets the ultrathin thicknesses in applicant par. 78, middle (for example thickness equals (od-id)/2); (600-400)/2 = 100 microns = 100 μm). Thus the Young needle is ultrathin-walled.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Lewis in view of Yokokawa and Petrides as taught by Young in order to facilitate using a needle size compatible with hydrogels and/or to use the needle of Lewis in view of Yokokawa, Petrides and Young for biocompatible alloplastic implant procedure (see Young par. 18, top).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis as evidenced by Ryan, in view of Yokokawa and Petrides as applied to claim 1 above, and further in view of US 3048172 (Krueger).
Regarding claim 14, Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above including syringe barrel (see annotated figure above) and a needle (see annotated figure above). Lewis does not disclose an attachment to prevent the needle from separating.
Krueger teaches a syringe (see title) and further teaches an attachment 20 to prevent a needle (see col. 2, ll. 1-5) from separating (see col. 1, ll. 40-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Lewis in view of Yokokawa and Petrides with an attachment to prevent the needle from separating as taught by Krueger in order to facilitate improving life cycle of syringe (see Krueger col. 1, ll. 20-25).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis as evidenced by Ryan, in view of Yokokawa and Petrides as applied to claim 1 above, and further in view of US 11,679,177 B2 (Barry).
Regarding claim 15, Lewis in view of Yokokawa and Petrides teach the current invention as claimed and discussed above. Lewis does not disclose said syringe barrel further comprises finger flanges.
Barry teaches (see fig. 1) a syringe 110 that injects hydrogel related material (see col. 16, ll. 45-50) and further teaches a syringe barrel 114 comprising finger flanges (see claim 1, top stating barrel includes finger flanges and annotated figure below showing the instant finger flanges).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Lewis in view of Yokokawa and Petrides with finger flanges in order to facilitate improving the user’s grasp of the syringe and to prevent slippage and mishandling (see col. 19, ll. 55-60 discussing that finger grips associated with syringes improve user handling of the syringe).
Regarding claim 16, The combination of Lewis in view of Yokokawa, Petrides and Barry teach the current invention as claimed and discussed above. The combination teaches wherein said finger flanges resist a force greater than needed to eject said hydrogel. The force needed to eject hydrogel varies on how fast the ejection is, the density of the hydrogel and the size of the outlet of the syringe, and further varies regarding the initial force to start the ejection and a continuing force to keep the plunger in motion (see Lewis par. 4, bottom). Thus the finger flange at least resists a force greater than a force for a low acceleration or speed, or regarding the continuous force. It is noted that “resist a force greater than needed to eject said hydrogel” is intended use and the prior art need only be capable of performing the intended use.
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Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
larger surface area results in more stable ergonomic thumb rest: US 20080195059 (par. 23); and
larger surface area results in a thumb rest that can accommodate an increased force: US 20130012918 (par. 59).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARC J AMAR whose telephone number is (571)272-9948. The examiner can normally be reached M-F 9:00-6:00.
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, Devon Kramer can be reached at (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARC AMAR/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741
1 This is interpreted with regarding to the standard in applicant par. 78, middle (i.e., less than 150 μm).