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 .
Election/Restrictions
Applicant’s election without traverse of \Invention I, Species 1 (claims 1 - 10 and 12 - 13) in the reply filed on 7/1/2026 is acknowledged.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 - 10 and 12 - 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 18 of U.S. Patent No. 12,201,856. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to structures for modifying ultrasound treatment involving a first material that forms an outer casing and surrounds a disk. In particular, the instant claims are directed to a manufacturing process that produces the structure of the reference claims.
Instant claims 1, 5, and 10 are suggested by reference claims 1, 10, 12 and/or 14. 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 invention of the reference claims to employ insert molding as the structure’s manufacturing technique, in order to take advantage of well-known and conventional manufacturing processes, thereby minimizing manufacturing complexity and expense.
Instant claim 2 is suggested by reference claim 5.
Instant claims 3 and 6 - 7 are suggested by reference claims 2 - 3. 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 invention of the reference claims to keep the curing temperature less than 170 degrees in order to avoid damaging the foam.
Regarding instant claim 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 invention of the reference claims to not degas the first material in order to avoid unnecessary manufacturing steps.
Regarding instant claim 8, 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 invention of the reference claims to have the curing occur after the introduction of the second layer, in order to strengthen the structure as a whole, as opposed to strengthening individual portions of the structure.
Instant claim 9 is suggested by reference claim 4.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 - 2, 5, 8 - 10, and 12 - 13 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Formlabs (Formlabs (2020, July 1). “Overmolding and Insert Molding: From Prototyping to Production”. https://formlabs.com/blog/overmolding-insert-molding/) in view of Cornwell et al. (US 2008/0061466).
Regarding claim 1, examiner notes that due to excessive breadth, the claim reads on a generic process of single or multi-shot insert molding, which is universally well-known in the manufacturing arts and has been conventionally used to manufacture countless consumer products for decades. For example:
Formlabs shows a method comprising:
introducing a first layer of a first material into a mold in a first stage of a molding process (“secondary part is formed over a substrate”, page 5: the “first material” is mapped to the injected secondary part; the “first layer” is mapped to an initially injected portion of the secondary part (e.g., a first third, half, etc. of the injected secondary part); the “first stage” is mapped to the duration time that the “first layer” is injected);
inserting a disk (“prefabricated part … inserted into a mold”, page 5; “… embed electronics into plastics”, page 6; “create plastic housings (that can be sterilized) for life-saving medical devices and implants … sensors, gears, fasteners, and other automotive parts”, page 7; “Toothbrushes, cell phone cases, and thumb drives … housing for GPS units and navigational devices … Defibrillators, medical cables, and wiring are often encased in plastic using insert molding”, page 9; “pacemakers, … camera equipment used for internal imaging”, page 10) into the mold, wherein the disk is surrounded by a peripheral gap between the disk and the mold (see gap in figured on page 5);
introducing a second layer of the first material into the mold in a second stage of the molding process, wherein the second layer of the first material fills the peripheral gap to provide a physical connection with the first layer (“secondary part is formed over a substrate”, page 5: the “first material” is mapped to the injected secondary part; the “second layer” is mapped to a later-injected portion of the secondary part (e.g., a last third, half, etc. of the injected secondary part); the “second stage” is mapped to a duration time encompassing the “second layer” being injected); and
curing the first layer and the second layer of the first material to form an outer casing (“create plastic housings (that can be sterilized) for life-saving medical devices and implants … sensors, gears, fasteners, and other automotive parts”, page 7; “Toothbrushes, cell phone cases, and thumb drives … housing for GPS units and navigational devices … Defibrillators, medical cables, and wiring are often encased in plastic using insert molding”, page 9; “pacemakers, … camera equipment used for internal imaging”, page 10 --- all of these products are created by “curing” as recited. Also refer to ‘curing’ step 10 on page 17.)
Although Formlabs is interpreted as meeting the claim as discussed above, Formlabs does not explicitly discuss the first material being supplied as first and second ‘layers’. Therefore in the interest of compact prosecution, an additional reference is being supplied that explicitly discusses that introducing a first material in a mold comprises introducing first and second layers of the first material.
Cornwell discloses extrusion-molding techniques. Cornwell teaches that introducing a first material in a mold comprises introducing first and second layers of the first material (“insert may be placed on top of the first extruded layer prior to or instead of layering the first layer with a second extruded layer. This form of "layering" can facilitate the formation of a structure having multiple layers of thermoplastic material, of the same or different composition, and layers of different inserted materials”, [0119]).
Therefore, assuming arguendo that Formlabs ‘layers’ do not meet the claim, 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 invention of Formlabs to have the introduction of the first material in the mold comprise introducing first and second layers of the first material, as taught by Cornwell, in order to facilitate the formation of a structure having multiple layers of thermoplastic material of the same composition, as suggested by Cornwell ([0119]), for example to control the relative placement of the disk within the outer casing and/or to completely embed the disk within the outer casing.
Regarding claim 2, Formlabs, either alone or in view of Cornwell, discloses the claimed invention substantially as noted above. Formlabs further shows that the mold has a circular geometry, and the peripheral gap is an annular region (see figure on page 5 showing circular geometry at least on the up/down axis; alternatively, refer to “plastic housings (that can be sterilized) for life-saving medical devices and implants … sensors, gears, fasteners, and other automotive parts”, page 7; “Toothbrushes, cell phone cases, and thumb drives … housing for GPS units and navigational devices … Defibrillators, medical cables, and wiring”, page 9; “pacemakers, … camera equipment used for internal imaging”, page 10 --- at least one of which comprises a mold with a circular geometry and an annular gap).
Alternatively, 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 invention of Formlabs, either alone or in view of Cornwell, to have the mold have a circular geometry and the gap be annular, in order to manufacture an outer casing that ais round along at least one dimension, as changes in shape to yield predictable results is prima facie obvious. See MPEP 2144.04.IV.B.
Regarding claim 5, Formlabs, either alone or in view of Cornwell, discloses the claimed invention substantially as noted above. Formlabs further shows that the disk comprises a second material that differs in composition from the first material and that has a higher acoustic attenuation of ultrasound energy of ultrasound energy than the first material (see figure on page 5; alternatively, refer to “plastic housings (that can be sterilized) for life-saving medical devices and implants … sensors, gears, fasteners, and other automotive parts”, page 7; “Toothbrushes, cell phone cases, and thumb drives … housing for GPS units and navigational devices … Defibrillators, medical cables, and wiring”, page 9; “pacemakers, … camera equipment used for internal imaging”, page 10. The relative acoustic attenuations of the materials are implicit, with at least one of the thermoplastic/silicone housings having a lower acoustic attenuation than the corresponding disk (i.e., tool, sensor, chip, etc.).
Regarding claim 8, Formlabs, either alone or in view of Cornwell, discloses the claimed invention substantially as noted above. Formlabs further shows that the first layer and the second layer of the first material are cured after the second layer of the first material is introduced into the mold in the second stage of the molding process, as the “second stage” is interpreted as encompassing the curing stage.
Regarding claim 9, Formlabs, either alone or in view of Cornwell, discloses the claimed invention substantially as noted above. Formlabs further shows that the disk is centrally located in the outer casing (see figure on page 5; alternatively, refer to “plastic housings (that can be sterilized) for life-saving medical devices and implants … sensors, gears, fasteners, and other automotive parts”, page 7; “Toothbrushes, cell phone cases, and thumb drives … housing for GPS units and navigational devices … Defibrillators, medical cables, and wiring”, page 9; “pacemakers, … camera equipment used for internal imaging”, page 10 --- at least one of which comprises the disk being centrally located in the outer casing).
Regarding claim 10, Formlabs, either alone or in view of Cornwell, discloses the claimed invention substantially as noted above. Formlabs further shows that the first material is either opaque or translucent to an extent sufficient to prevent visualization of the disk through the outer casing (see figure on page 5; alternatively, refer to “plastic housings (that can be sterilized) for life-saving medical devices and implants … sensors, gears, fasteners, and other automotive parts”, page 7; “Toothbrushes, cell phone cases, and thumb drives … housing for GPS units and navigational devices … Defibrillators, medical cables, and wiring”, page 9; “pacemakers, … camera equipment used for internal imaging”, page 10 --- at least one of which is either opaque or translucent to an extent sufficient to prevent visualization of the disk through the outer casing).
Regarding claims 12 - 13, Formlabs, either alone or in view of Cornwell, discloses the claimed invention substantially as noted above. Formlabs further shows that the molding process forms a pad that is wedge shaped (refer to “plastic housings (that can be sterilized) for life-saving medical devices and implants … sensors, gears, fasteners, and other automotive parts”, page 7; “Toothbrushes, cell phone cases, and thumb drives … housing for GPS units and navigational devices … Defibrillators, medical cables, and wiring”, page 9; “pacemakers, … camera equipment used for internal imaging”, page 10 --- at least one of which is interpreted as a pad that is wedge-shaped). The pad is at least physically capable of being used in some unspecified manner in an ultrasound treatment in which a subject of the ultrasound treatment is unaware of a treatment condition.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Formlabs, either alone or in view of Cornwell, as applied to claim 1 above, and further in view of Anderson et al. (US 2005/0215901).
Regarding claim 3, Formlabs, either alone or in view of Cornwell, discloses the claimed invention substantially as noted above.
Formlabs is not specific to the disk being maintained at a temperature of less than 170°C during the first stage and the second stage of the molding process.
Anderson discloses manufacturing processes for ultrasound coupling media. Anderson teaches maintaining at a temperature of less than 170°C during a molding process ([0101]).
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 invention of Formlabs, either alone or in view of Cornwell, to include maintaining at a temperature of less than 170°C during the molding process, as taught by Anderson, in order to optimize the manufacturing process by selecting appropriate temperatures for the materials being used, as is notoriously well-understood in the manufacturing arts.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Formlabs, either alone or in view of Cornwell, as applied to claim 1 above, and further in view of Li et al. (US 2019/0106550).
Regarding claim 4, Formlabs, either alone or in view of Cornwell, discloses the claimed invention substantially as noted above.
Formlabs is not specific to the first material not being degassed before or during the molding process.
Li discloses manufacturing processes. Li teaches a first material not being degassed before or during the molding process (“ … extruded without venting or degassing to induce the formation of cells within the material …” [0036] - [0037]).
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 invention of Formlabs, either alone or in view of Cornwell, to have the first material not be degassed before or during the molding process, as taught by Li, in order to induce the formation of cells within the material, as suggested by Li ([0036] - [0037]).
Claims 6 - 7 are rejected under 35 U.S.C. 103 as being unpatentable over Formlabs, either alone or in view of Cornwell, as applied to claim 5 above, and further in view of Hewes (US 2019/0321122, of record).
Regarding claims 6 - 7, Formlabs, either alone or in view of Cornwell, discloses the claimed invention substantially as noted above.
Formlabs is not specific to the second material comprising open-cell or closed-cell foam.
Hewes discloses disposable kits configured to use in a medical procedure. Hewes teaches a second material comprising open-cell or closed-cell foam (“ … closed cell foam, open cell foam …” [0131]).
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 invention of Formlabs, either alone or in view of Cornwell, to have the second material comprise open-cell or closed-cell foam, as taught by Hewes, in order to manufacture a product with foam cushioning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
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