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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 (“RCE”), including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1 December 2025 (“Reply”) has been entered.
Response to Amendment
This Action is responsive to the RCE and Reply. As directed in the Reply:
Claims 1, 3, 4, 7, 15, and 16 have been amended;
Claims 2 and 6 has been and/or remain cancelled; and
Claim 20 has been added.
Thus, Claims 1, 3-5, and 7-20 are presently pending in this application, with Claim 9 having been previously withdrawn from consideration.
Applicant’s amendment to the Abstract and Claims 2, 4, 7, and 15-17 are sufficient to overcome the objections and rejections from the previous Action, as indicated in the Advisory Action dated 4 November 2025, and are therefore withdrawn.
Response to Arguments
Applicant’s arguments with respect to Claims 1, 3-5, 7, 8, and 10-20 have been considered but are mostly unpersuasive.
Lack of Unity of Invention
Because Claim 1 is still not free of the prior art, the claims still lack unity under PCT Rule 13.
Rejections over the prior art
Claim 1 has been amended to introduce a microarray, with a convex receiving portion, into the preamble of the claim, and to reference that convex receiving portion in the last paragraph of the claim in a clause that includes both functional features of the positively claimed convex structure of the plunger, and intended use of that structure with the unclaimed microarray. A portion of the last clause of the last paragraph, “configured to directly contact the convex receiving portion,” has been treated as if the words “were the unclaimed microarray positioned correctly” are appended to its end, because this clause attempts to derive limitation from an unclaimed environmental workpiece. See M.P.E.P. § 2111.02 concerning the treatment of the preamble, and 2173.05(g) concerning the functional language in the claim.
Because Claim 1 et sqq. do not positively claim the microarray and its convex receiving portion, and Todd’s hammer includes a convex portion as otherwise claimed, the amendments to Claim 1 do not free the claims of the prior art because, were a microarray as defined in the claim’s preamble positioned as required by the claim, a Trautman-Todd device would perform the claimed function in exactly the same manner as claimed and as does Applicant’s disclosed device.
Applicant argues (Reply, pg. 8, first full paragraph) that Troutman’s device does not include an actuation surface opposite a convex structure. While this is likely true, it is Todd that supplies the convex structure, not Trautman, as indicated in the Advisory Action, and Trautman certainly has an actuation surface on its top.
Applicant then argues (Reply, pg. 8, third and fourth full paragraphs) that the prior art does not disclose a microarray with a convex receiving portion, and therefore Claim 1 is patentable. Applicant’s arguments focus on Todd’s element 35, relied upon in the prior Action; however, in that Action, the embodiment of Todd’s Figs. 4A and 4B was specifically referenced as disclosing features which may be read on by Applicant’s then-proposed, now-presented claim features. As detailed below, Todd’s Figs. 4A and 4B also render Claim 1 et sqq. unpatentable to Applicant. As explained elsewhere herein, because the microarray is not positively claimed, cf. Claim 20, there is no structural or functional difference between Claim 1 and a Trautman-Todd device.
Concerning Claim 14, while the claim positively recites a microarray, the claim does not require that it is the same microarray of Claim 1’s preamble.
Claim Interpretation
Claim 1 uses the word “punctual” which, while antiquated, is understood to mean “pertaining to or of the nature of a point” (www.dictionary.com/browse/punctual), which is read in the context of the underlying original disclosure.
Claim 7 uses the term “a fit” without the further characterizations deleted in the Reply. The following definitions were located, which inform an understanding of the term.
themechanicalengineering.com/types-of-fit/
“Fits are assembly conditions between Hole and Shaft. With fits, we understand how tight and loose the two components are connected. So it is a mating relationship between two components.”
learnmech.com/engineering-fits-clearance-transition-interference-fit/
“The relationship existing between two parts, shaft, and hole, which are to be assembled, concerning the difference in their sizes before assembly, is called a fit.”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-5, 7, 8, and 10-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 20, at the penultimate line of each, recite that a “convex structure . . . configured to directly contact the convex receiving portion” (emphasis added). The Examiner has fully reviewed the entire application as filed, and finds no support for the convex structure directly contacting the convex receiving portion; instead, in all embodiments that are currently read on by the pending claims, a “cover film 38” is positioned between the two convex portions, preventing their “direct” contact. Indeed, this Application makes clear that the cover film 38 is included to enhance sterility of the microarray prior to its use.
Therefore, there is insufficient evidence in the record to support a conclusion that the inventors had, as of the filing date of the application, possession of the entire scope of the invention as recited in each of Claims 1 and 20. The remaining claims depend from Claim 1, inherit but do not cure this defect, and therefore are also rejected for the same reason.
Claim Rejections - 35 USC § 103
Claims 1, 3-5, 7, 8, 10-13, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2011/0276027, by Trautman et al. (“Trautman”) in view of U.S. Patent App. Pub. No. 2020/0101205, by Todd et al. (“Todd”).
Trautman describes a device substantially as claimed by Applicant, as follows.
Claim 1: An applicator (10; see [0059] - [0062], [0071], [0076], [0080], [0089] and [0093], and Figs. 1A - 1E) for applying a microarray ([0059]), the microarray having a convex receiving portion (see treatment above), the applicator comprising:
a cylindrical housing (16) and
a plunger (24) for acceleration of the microarray ([0080]), the plunger being movable inside the housing (id.), the plunger having a first side (top of 20) and a second side opposite the first side (at 22),
a target force trigger (20; [0059] and [0071]), the target force trigger fixing the plunger relative to the cylindrical housing and releasing the plunger for movement relative to the cylindrical housing when at least a target force is applied ([0059] and [0071]; Figs. 1A - 1E); and
an actuation surface for the application of the target force (top surface of 20; see [0071]-[0072]), the actuation surface being connected with the first side of the plunger (see Fig. 1E, among others).
Trautman does not, however, describe:
a hinge device for movability of the plunger relative to the cylindrical housing; or
a convex structure connected with the second side of the plunger for transmitting a punctual force to the microarray to be applied and configured to directly contact the convex receiving portion, the convex structure oriented opposite the actuation surface.
Todd relates to medical microarray applicators and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Todd teaches that such device can be provided with a number of features relevant to the current claims, including:
Figs. 4A, 4B, a hammer 67 on the lower side of an actuator, which is both convex and applies a punctual force to a plunger 59 and/or 77, which a person of ordinary skill in the art would understand makes the device more reliable because the hammer does not have to line up precisely with the plunger 59 and/or 77 in order to function, but instead can be somewhat misaligned and still function; and
a “hinge” can be provided, Figs. 4A, 4B, which a person of ordinary skill in the art understands takes advantage of the moment arm created by the hinge, to amplify the force applied and thus reduce the effort by the user to apply the microarray to the patient.
It 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, to construct Trautman‘s device to include both a hinge device for movability of the plunger relative to the cylindrical housing, and a convex structure connected with the second side of the plunger for transmitting a punctual force to the microarray to be applied and configured to directly contact the convex receiving portion, the convex structure oriented opposite the actuation surface, because Todd teaches doing so in a closely-related device, which takes advantage of the moment arm created by the hinge, to amplify the force applied and thus reduce the effort by the user to apply the microarray to the patient, and to improve the reliability of the device. Once supplied with the features from Todd, the convex structure will function as recited in Claim 1 with the unclaimed microarray, as discussed above.
Claim 3: (The applicator according to claim 1,) wherein the actuation surface (top of 20) is accessible from outside the applicator (Trautman [0071]-[0072]).
Claim 4: (The applicator according to claim 1,) further comprising:
a spring sheet (Trautman spring 30) that indirectly or directly prestresses the plunger (moves the plunger upward when it is down), to create a prestress which moves the plunger after a movement release (after plunger movement is released).
Claim 5: (The applicator according to claim 1,) wherein the plunger is rigid (Trautman’s plunger 20 is formed of a solid material and displays no flexing; compare Figs. 1B and 1E).
Claim 7: (The applicator according to claim 1,) wherein the target force trigger comprises a rated breaking point (unelected species) and/or a fit, the rated breaking point and/or the fit being between the housing and the plunger (Trautman Fig. 1B, radial bead of 20, near the end of the lead line for ref. no. 14, fits up against the interior of the housing).
Claim 8: (The applicator according to claim 1,) wherein the hinge device is a flexure hinge device (Todd: spring 78, which is part of the hinge device, flexes).
Claim 10: (The applicator according to claim 1,) comprising a retaining device for the fixation of the plunger after movement release (Trautman: Fig. 2A, latching device 112, 116).
Claim 11: (The applicator according to claim 1,) wherein the plunger is configured to be connected directly or indirectly with the microarray (indirectly; see Trautman [0080]).
Claim 12: (The applicator according to claim 1,) further comprising a connection device for the connection of the applicator with a microarray receiving portion and/or an application site (Trautman’s connection device 12, for connection to a patient’s skin, which is an application site).
Claim 13: (The applicator according to claim 12,) wherein the connection device comprises a thread and/or a plug-in connector and/or a form-fitting connection element (Trautman’s element 12 form fits to the patient’s skin, when pressed against it) and/or a flange and/or an adhesive connection device and/or a lug and/or a loop.
Claim 18: (The applicator according to claim 10,) wherein the retaining device is a latching device (Trautman: Fig. 2A, latching device 112, 116).
Claim 19: (The applicator according to claim 7,) wherein the fit comprises a bead and/or a groove (Trautman Fig. 1B, radial bead of 20, near the end of the lead line for ref. no. 14).
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Trautman and Todd as applied against Claim 1 above, and further in view of U.S. Patent App. Pub. No. 2020/0331691, by Sakazaki (“Sakazaki”).
Trautman and Todd together describe a device substantially as claimed by Applicant; see above. In addition, and with respect to Claim 14, Trautman and Todd both describe a microarray (Trautman passim; see, e.g., [0070]-[0071]; Todd, 53) with a microarray receiving portion (Todd, 77), the microarray receiving portion being arranged relative to the applicator and/or being connected with the applicator such that the plunger applies the microarray (Trautman [0070]-[0071]; Todd, Fig. 4B); with respect to Claim 15, the microarray receiving portion comprises a first side and a second side (id.); and, with respect to Claim 16, a force application structure (Todd, 59), the plunger of the applicator acting indirectly or directly on the force application structure (Todd, Fig. 4B, showing the plunger 67 pressing the pressure element 59 against the plunger 77).
They do not, however, describe that:
the microarray receiving portion is connected with a microarray receiving portion cluster (Claim 14);
the microarray receiving portion comprises: a carrier structure for the connection of the microarray receiving portion with an application site, a carrier surface connected with the carrier structure, the microarray connected with the carrier surface, and the microarray receiving portion hinge device (see treatment above) between the carrier surface and the carrier structure, the microarray receiving portion hinge device allowing for a movement of the microarray connected with the carrier surface along the extension of the microarray relative to the carrier structure (Claim 15);
the force application structure is connected with the rear side of the carrier surface (Claim 16); or
the force application structure extends convexly from the rear side of the carrier surface (Claim 17).
Sakazaki relates to medical microarray applicators and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Sakazaki teaches (see Figs. 10, 11, and 14) that such devices can be constructed with the following features, and for the following reasons:
the microarray receiving portion is connected with a microarray receiving portion cluster (Fig. 11, cluster 1, microarray receiving portion 10; so that the devices can be effectively mass produced from sheets of material);
the microarray receiving portion comprises (Fig. 14): a carrier structure for the connection of the microarray receiving portion with an application site (11, 51), a carrier surface (17) connected with the carrier structure, the microarray connected with the carrier surface (at the end of 17), and a microarray receiving portion hinge device between the carrier surface and the carrier structure (14b), the microarray receiving portion hinge device allowing for a movement of the microarray connected with the carrier surface along the extension of the microarray relative to the carrier structure (see the 3rd and 4th portions of Fig. 14; [0118]-[0123]) (all for the purpose of containing the microarray and modularly allowing it to be applied to the patient only when force is applied to the upper surface of the carrier);
the force application structure is connected with the rear side of the carrier surface (“rear” not defined with respect to the other structures of the claim; connected at 54, so that the microarray is retained within the carrier); and
the force application structure extends convexly from the rear side of the carrier surface (Todd’s pressure element 59 is shown to be curved away from its plunger 77 in Fig. 4B; thus, when applied with Sakazaki’s carrier structures, pressure element 59 will extend as claimed; this better assures that the pressure element will strike the microarray, just as with the shape of the element 67).
It 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, to construct Trautman/Todd‘s device to include the foregoing additional features of Claims 14-17, because Sakazaki teaches doing so in a closely-related device for the foregoing reasons.
Allowable Subject Matter
Claim 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) set forth in this Office Action.
The following is a statement of reasons for the indication of allowable subject matter.
The prior art of record, taken both alone and in permissible combination, fails to identically disclose or fairly suggest the combinations of features recited in Claim 20. More specifically, there is not sufficient evidence in the record to support a conclusion that it would have been obvious to modify any of the devices described in the prior art of record, including those of Trautman and Todd, to further include a microarray having a convex receiving portion, and a convex structure connected with the second side of a plunger for transmitting a punctual force to the microarray to be applied and configured to directly contact the convex receiving portion, the convex structure oriented opposite an actuation surface. While the embodiment illustrated in, and described with reference to, Todd’s Figs. 4A and 4B includes a convex structure at the tip of element 67, which corresponds to the claimed “convex structure” (see discussion above concerning Claim 1), none of the prior art discloses a microarray with a convex receiving portion. Indeed, Todd specifically teaches away from having two convex structures at [0124], stating that the two surfaces should instead be ‘complementary,’ i.e., one convex and one concave.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 01/08/2026