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 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.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1 and 3-9 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 elasticity of the containing indentation and the fixing indentation” in lines 17-18, but it is not clear if this recitation is intended to mean that both indentations have the same elasticity or if “the elasticity” was intended to be “the elasticities”. Relatedly, the recitations raise the question as to whether the indentations are made of the same material or integrally formed as one piece. These ambiguities render claim 1 indefinite.
Claims 3-9 are rejected by virtue of their dependence from claim 1.
Claim 6 recites “an elastic element” in lines 1-2, but it is not clear if this recitation is the same as, related to, or different from “an elastic element” of claim 1, line 15. If they are the same, “an elastic element” in claim 6 should be “the elastic element”. Although this interpretation raises the question as to whether the blocking element and the septum are meant to be a single piece or two different pieces. If the former, the claim’s presentation of these two elements as separate and distinct runs counter to the blocking element and the septum being a single piece. If the later and the two elastic elements are different, these elements should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 8 recites “wherein the septum prevents a filler disposed in the fixing indentation from overflowing into the containing indentation” in lines 1-2, but it is not clear if the filler is part of the claimed holder. The claim does not explicitly list this filler as a claimed element. If it is a claim element, it should be made clear that it is part of the claimed holder. If it is not, the claim recitation reads as a method step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
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.
Claims 1 and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2021/0030320 (Huang)(previously cited), in view of JP 2005-10056 (Junichi). Citations to Junichi will refer to the machine English translation that accompanies this Office Action.
The present application claims priority to U.S. Patent Application 16/945634 (the 634 application), filed on 7/31/2020. However, the 634 application does not support the claimed subject matter of the present application. In particular, the 634 application does not disclose “a septum disposed between the containing indentation and the fixing indentation, and configured to hold a second part of the sensor, wherein the septum is an elastic element and closes off the containing indentation from the fixing indentation except for a slot through which the sensor passes, and wherein an elasticity of the elastic element is greater than the elasticity of the containing indentation and the fixing indentation” of claim 1. As a result, the claims of the present application are not entitled to the benefit of the 7/31/2020 filing date of the 634 application (see MPEP 211.05: “Only the claims of the continuation-in-part application that are disclosed in the manner provided by 35 U.S.C. 112(a) in the prior-filed application are entitled to the benefit of the filing date of the prior-filed application”.). The effective U.S. filing date of the claimed subject matter of the present application is 5/4/2023. Further, Huang is considered prior art under 35 U.S.C. 102 against the claims of the present application because it has a publication date (2/4/2021) of more than one year before the effective U.S. filing date of the claimed subject matter of the present application (5/4/2023).
With respect to claim 1, Huang teaches a holder (the holder 20 of Huang) carrying thereon a sensor (the sensor 40 of Huang) having a signal detection end (the signal detection end 44 of Huang) and a signal output end (the signal output end 42 of Huang) to measure a physiological signal of an analyte in a biological fluid, wherein a top of the holder is positioned lower than a top of the signal output end such that the signal output end protrudes beyond the holder (see FIG. 6 of Huang), comprising:
an implantation hole (the implantation hole 24 of Huang) being a channel configured to implant the sensor, and containing a first part of the sensor;
a containing indentation (the containing indentation 22 of Huang) on which the signal output end is disposed;
a fixing indentation (the fixing indentation 27 of Huang) configured to fix thereto the sensor and communicate with the containing indentation;
a waterproof seal (the waterproof seal 25A of Huang) disposed above the implantation hole;
an elastic divider (the elastic divider 25B of Huang) disposed in the implantation hole to separate the implantation hole into two parts and having a cross sectional area that is equal to or greater than a cross-sectional area of the implantation hole (see FIG. 6 of Huang; paragraph 0041 of Huang).
Huang does not teach a septum disposed between the containing indentation and the fixing indentation, and configured to hold a second part of the sensor. Junichi teaches a circuit board 6 formed in slot of an insulating substrate made from an epoxy or silicone resin material containing glass fiber or ceramic (paragraphs 0023 and 0032 and FIG. 5 of Junichi). The epoxy or silicone resin is applied in the space to which the circuit board 6 is inserted (paragraph 0023 and FIG. 5 of Junichi). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place an epoxy or silicone resin with an accommodating slot in the space defined by the containing indentation 22 and the fixing indentation 27 of Huang so as to protect the structure. Thus, the combination teaches or suggest a septum (The epoxy or silicone resin residing in the containing indentation 22 and the fixing indentation 27) between the containing indentation and the fixing indentation (since the epoxy or silicone resin resides in the containing and fixing indentations, it necessarily resides between the two indentations), and configured to hold a second part of the sensor, wherein the septum is an elastic element and closes off the containing indentation from the fixing indentation except for a slot through which the sensor passes (since the epoxy or silicone resin resides in the containing and fixing indentations, it necessarily closes off the containing indentation from the fixing indentation except for a slot through which the sensor passes), and wherein an elasticity of the elastic element is greater than the elasticity of the containing indentation and the fixing indentation (the epoxy or silicone resin is of greater elasticity than the indentations since the holder is made of hard material (paragraph 0035 of Huang).
With respect to claim 3, the combination teaches or suggests that the fixing indentation further comprises a positioning groove (the element A in the below annotated FIG. 7B of Huang) on a surrounding wall of the fixing indentation.
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Annotated FIG. 7B of Huang
With respect to claim 4, the combination teaches or suggests that the holder further comprises a limiter (the limiters 29 of Huang) arranged adjacent to the fixing indentation (the fixing indentation 27 of Huang) to hold the sensor (the sensor 40 of Huang) in the holder.
With respect to claim 5, the combination teaches or suggests that the holder further comprises a blocking element (the blocking element 25C of Huang) disposed in the implantation hole (the implantation hole 24 of Huang) hole to hold the sensor (the sensor 40 of Huang) in the holder (see FIG. 7A of Huang).
With respect to claim 6, the combination teaches or suggests that the blocking element is an elastic element (paragraph 0043 of Huang).
With respect to claim 7, the combination teaches or suggests that the elastic divider (the elastic divider 25B of Huang) is disposed above the sensor (the sensor 40 of Huang) in the implantation hole (the implantation hole 24 of Huang; see FIG. 6 of Huang).
With respect to claim 8, the combination teaches or suggests that the septum prevents a filler disposed in the fixing indentation from overflowing into the containing indentation (since the epoxy or silicone resin resides in the containing and fixing indentations, it necessarily prevents the glue 28 disposed in the fixing indentation from overflowing into the containing indentation).
With respect to claim 9, the combination teaches or suggests that the slot is a sole opening between the containing indentation and the fixing indentation through which the fixing indentation communicates with the containing indentation (the slot for the sensor is the only opening in the epoxy or silicone resin that resides in the containing and fixing indentations).
Response to Arguments
The Applicant's arguments filed 7/21/2026 have been fully considered.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 7/21/2026, the previous claims rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn. However, there are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 7/21/2026.
Prior art rejection
The Applicant’s arguments with respect to the rejection of claims 1 and 3-9 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. That is, there are new grounds of rejection that were necessitated by the claim amendments filed on 7/21/2026.
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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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