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 .
Claim Objections
Claims 1 and 20 are objected to because of the following informalities:
Claim 1 is objected to because the semicolons should be changed to commas.
Claim 20 is objected to because the semicolon in line 4 should be changed to a comma.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 - 6, 8, 15 - 16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larson et al. (US 6,039,694).
Regarding claim 1, Larson shows a hydrogel couplant system for use in ultrasonic imaging (fig. 4), the couplant system comprising: a sleeve body (hydrogel sheath 3, fig. 4) comprising a hydrogel couplant material (hydrogel sheath, col. 4, lines 64 - 66 and fig. 1), wherein the sleeve body is configured to partially encapsulate an ultrasonic probe (“… hydrogel sheath 3 … external surface 4 covering the entire medical ultrasound transducer body 1 …,” col. 6, lines 12 - 23), and the hydrogel couplant material is configured to cover an acoustic window of the ultrasonic probe (col. 6, lines 12 - 23).
Regarding claims 2 - 3, Larson discloses the claimed invention substantially as noted above. Further, the hydrogel couplant system of Larson is at least physically capable of being used for ultrasonic intraoral imaging, and for ultrasonic periodontal imaging, and therefore meets the claims.
Regarding claim 4, Larson discloses the claimed invention substantially as noted above. Larson further shows that the hydrogel couplant material is a multicomponent composite hydrogel material (“hydrogel sheath … multi block structure…”, col. 4 line 64 - col. 5, line 1).
Regarding claims 5 - 6, Larson discloses the claimed invention substantially as noted above. It is noted that the probe is not part of the claimed invention. The hydrogel couplant system of Larson is at least physically capable of being used with an ultrasonic probe comprising a transducer (see abstract, inter alia), and therefore meets the claims.
Regarding claim 8, Larson discloses the claimed invention substantially as noted above. Larson further shows that the sleeve body is hypoallergenic (i.e., unlikely to cause an allergic reaction) (“eliminates biological reactions from latex contact …”, abstract; “… microbial barrier that replaces protective latex or synthetic covers … sterilizable and biocompatible … introduces no harmful residue …”, col. 4, lines 40 - 57; “… intracavity …”, col. 6, lines 12 - 23; col. 9, lines 25 - 30, col. 10, lines 3 - 5).
Regarding claim 15, Larson discloses the claimed invention substantially as noted above. Larson further shows that the sleeve body comprises a polymer (col. 3, lines 37 - 46; col. 4, line 64 - col. 5, line 19).
Regarding claim 16, Larson discloses the claimed invention substantially as noted above. Larson further shows that the hydrogel couplant material is integrally formed within the body of the sleeve (“sheet form … hydrogel sheet 3…”, col. 4, lines 64 - 66 and fig. 1).
Regarding claim 20, Larson shows a hydrogel couplant system for use in ultrasonic imaging (fig. 4), the couplant system comprising:
a hydrogel couplant material (hydrogel sheath, col. 4, lines 64 - 66 and fig. 1); and
an ultrasonic probe (transducer body 1, column 6, lines 12 - 23 and fig. 4), wherein the hydrogel couplant material is configured to cover a portion of an acoustic window of the ultrasonic probe (“… hydrogel sheath 3 … external surface 4 covering the entire medical ultrasound transducer body 1 …,” column 6, lines 12 - 23).
Examiner note: Larson is interpreted as meeting the invention of claim 1, as discussed in the art rejections above. However, an additional rejection of claim 1 is being provided in order to provide the best available art rejections for selected dependent claims.
Claims 1 and 17 - 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Desai et al. (US 2017/0128042).
Regarding claims 1 and 17, Desai shows a hydrogel couplant system for use in ultrasonic imaging (abstract), the couplant system comprising: a sleeve body (ultrashield 10, [0056] and figs. 1 - 2) comprising a hydrogel couplant material (“couplant layer comprises a hydrogel”, [0013]; hydrogel, [0064] - [0065]), wherein the sleeve body is configured to at least partially encapsulate an ultrasonic probe (“…ultrashield 10 … affix to the faceplate 12 …”, [0056] and figs. 1 - 2), and the hydrogel couplant material is configured to cover an acoustic window of the ultrasonic probe ([0056] and figs. 1 - 2), wherein the couplant material (couplant layer 32, [0059] and figs. 4 - 5) is adhered (“…layers 30, 32, 34 … adhered together …”, [0059]) to an outer surface of the sleeve body (either of probe contact layer 30 or outer surface body contact layer 34, [0059] and figs. 4 - 5).
Regarding claims 18 - 19, Larson discloses the claimed invention substantially as noted above. Larson further shows that the hydrogel couplant material is configured to cover a portion of the outer surface of the sleeve body (figs. 4 - 5). The covered portion is interpreted as being “substantially all”, at least because the covered portion comprises the majority of the outer surface, as depicted in figs. 4 - 5.
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.
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 7 and 9 - 13 are rejected under 35 U.S.C. 103 as being unpatentable over Larson in view of Applicant Admitted Prior Art (hereinafter “AAPA”).
Regarding claims 7 and 11, Larson discloses the claimed invention substantially as noted above. Larson further shows that the hydrogel couplant material has an initial water percentage in the range of about 50% to about 90% (“water or saline content of about 70% to about 95%”, col. 6, lines 36 - 45).
Larson is silent as to whether or not the hydrogel couplant material comprises the recited material properties. However, Larson explains that “mechanical and chemical properties … can be optimized relative to specific products and processes by adjustment in polymer percentage, water and alkali salt content and chemical modifiers” (col. 3, lines 25 - 46).
Moreover, applicant admits in [0032] of the instant published specification that “known hydrogel materials” are suitable for use as the hydrogel couplant material, such that those of ordinary skill in the art would recognize the list of suitable “known hydrogel materials” in applicant’s disclosure as providing the recited material properties and/or as being suitably equivalent to the recited hydrogel couplant material.
It would therefore 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 Larson to have the hydrogel couplant material comprise the recited material properties, in order to
optimize the mechanical and chemical properties, as envisaged by Larson (col. 3, lines 25 - 46), and/or use known available hydrogel materials for the hydrogel couplant material, as suggested by applicant in [0032] of the instant published specification. Such modification would have comprised only routine optimization of result effective variables, and/or selection from amongst known materials on the basis of known suitability for an intended use, both of which have previously been held to involve only routine skill in the art.
Regarding claims 9 - 10, the combined invention of Larson and AAPA discloses the claimed invention substantially as noted above. Larson further shows that the sleeve body is antiviral and antibacterial (“… microbial barrier that replaces protective latex or synthetic covers … sterilizable and biocompatible … introduces no harmful residue …”, col. 4, lines 40 - 57; col. 9, lines 25 - 30, col. 10, lines 3 - 5).
Regarding claims 12 - 13, Larson discloses the claimed invention substantially as noted above.
Larson is silent as to whether or not the hydrogel couplant material comprises the recited material properties. However, Larson explains that “mechanical and chemical properties … can be optimized relative to specific products and processes by adjustment in polymer percentage, water and alkali salt content and chemical modifiers” (col. 3, lines 25 - 46).
Moreover, applicant admits in [0032] of the instant published specification that “known hydrogel materials” are suitable for use as the hydrogel couplant material, such that those of ordinary skill in the art would recognize the list of suitable “known hydrogel materials” in applicant’s disclosure as providing the recited material properties and/or as being suitably equivalent to the recited hydrogel couplant material.
It would therefore 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 Larson to have the hydrogel couplant material comprise the recited material properties, in order to
optimize the mechanical and chemical properties, as envisaged by Larson (col. 3, lines 25 - 46). Such modification would have comprised only routine optimization of result effective variables, which has previously been held to involve only routine skill in the art. See MPEP 2144.05.II.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Larson in view of Cox et al. (US 2013/0116571).
Regarding claim 14, Larson discloses the claimed invention substantially as noted above.
Larson fails is silent as to the sleeve body containing an additive selected from the group comprising: surfactants, anti-blocking agents, anti- foammants, monomers, crosslinkers, initiators, chain propagation agents, softeners, antibacterial agents, antiviral agents, flavorants, and food grade colorants.
Cox discloses hydrogel products.
Cox teaches a hydrogel comprising an additive comprising an antibacterial agent (“antibacterial/antimicrobial component could be added to the hydrogel formulation”, [0051]).
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 Larson to have the sleeve body contain an additive comprising an antibacterial agent, as taught by Cox, in order to help achieve Larson’s antimicrobial properties.
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