DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-8, 11-17 are pending.
This action is Final.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “expansion unit configured to”, “control unit configured to”, “display unit configured to”, “control unit functions to” in claims 1, 3-6, 12-15, 17.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Based on review of the disclosure as filed the following corresponding structures are:
“expansion unit configured to” corresponds to structures inside the flexible base which allow pressure from outside to inside the flexible base to expand.
“control unit configured to”, “control unit functions to” are merely repeated without any specific structures.
“display unit configured to” is repeated in the description, but based on the structures of the Figures is a display and equivalents.
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.
Claim 12-15, 17 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.
Regarding claims 12-15, 17, the features of a control unit configured to lacks proper written description. The claimed feature is a nonce term meeting the three prong analysis, but there is no clear corresponding structure disclosed, merely repeating of the nonce term in the disclosure as filed. As such, the claimed feature is rejected under both a and b of 112. MPEP 2181. The dependent claims are rejected for depending on a rejected claim.
Regarding claim 15, the limitations in addition to the lack of structure addressed prior, there is also a lack of algorithm for “wherein the control unit performs calculations to correct the oxygen saturation based on a value measured from the pressure sensor”, which lacks adequate written description. The disclosure as filed has no explanation as to how this calculation is completed by applicant to adequately support possession of the claimed invention at the time the application was filed. Although such step may be possible, this is not the test for compliance with the written description requirement. Rather, “the test for [written description] sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). In this case, Applicant merely establish that the inventor(s) could have had possession of the claimed subject matter as of the filing date, not that they did have possession at that time.
Federal Register Notice of January 7, 2019:
At issue in Vasudevan was whether the patent specification provided sufficient written description support for a limitation of the asserted claims. Vasudevan, 782 F.3d at 681–83. The Federal Circuit explained that ‘‘[t]he test for the sufficiency of the written description ‘is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.’ ’’ Id. at 682 (quoting Ariad, 598 F.3d at 1351). The Federal Circuit emphasized that ‘‘[t]he written description requirement is not met if the specification merely describes a ‘desired result.’ ’’ Vasudevan, 782 F.3d at 682 (quoting Ariad, 598 F.3d at 1349). Thus, in applying this standard to the computer-implemented functional claim at issue, the Federal Circuit stated that ‘‘[t]he more telling question is whether the specification shows possession by the inventor of how [the claimed function] is achieved.’’ Vasudevan, 782 F.3d at 683. In order to satisfy the written description requirement set forth in 35 U.S.C. 112(a), the specification must describe the claimed invention in sufficient detail such that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. For instance, the specification must provide a sufficient description of an invention, not an indication of a result that one might achieve. The level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Information that is well known in the art need not be described in detail in the specification. However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. See MPEP § 2163, subsection II(A)(2). The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated possession of the claimed invention. Id.; see also Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000) (‘‘The purpose of [the written description requirement] is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification’’); LizardTech Inc. v. Earth Resource Mapping Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005) (‘‘Whether the flaw in the specification is regarded as a failure to demonstrate that the applicant possessed the full scope of the invention recited in [the claim] or a failure to enable the full breadth of that claim, the specification provides inadequate support for the claim under [§ 112(a)]’’); cf. id. (‘‘A claim will not be invalidated on [§ ] 112 grounds simply because the embodiments of the specification do not contain examples explicitly covering the full scope of the claim language.’’). While ‘‘[t]here is no special rule for supporting a genus by the disclosure of a species,’’ the Federal Circuit has stated that ‘‘[w]hether the genus is supported vel non depends upon the state of the art and the nature and breadth of the genus.’’ Hynix Semiconductor Inc. v. Rambus Inc., 645 F.3d 1336, 1352 (Fed. Cir. 2011); id. (further explaining that ‘‘so long as disclosure of the species is sufficient to convey to one skilled in the art that the inventor possessed the subject matter of the genus, the genus will be supported by an adequate written description.’’). See also Rivera v. Int’l Trade Comm’n, 857 F.3d 1315, 1319–21 (Fed. Cir. 2017) (affirming the Commission’s findings that ‘‘the specification did not provide the necessary written description support for the full breadth of the asserted claims,’’ where the claims were broadly drawn to a ‘‘container . . . adapted to hold brewing material’’ while the specification disclosed only a ‘‘pod adapter assembly’’ or ‘‘receptacle’’designed to hold a ‘‘pod’’). Computer-implemented inventions are at times disclosed and claimed in terms of their functionality. For computer-implemented functional claims, the determination of the sufficiency of the disclosure will require an inquiry into the sufficiency of both the disclosed hardware and the disclosed software (i.e., ‘‘how [the claimed function] is achieved,’’ Vasudevan, 782 F.3d at 683), due to the interrelationship and interdependence of computer hardware and software. When examining computer implemented, software-related claims, examiners should determine whether the specification discloses the computer and the algorithm(s) that achieve the claimed function in sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as ‘‘a finite sequence of steps for solving a logical or mathematical problem or performing a task.’’ Microsoft Computer Dictionary (5th ed., 2002). Applicant may ‘‘express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure.’’ Finisar, 523 F.3d at 1340 (internal citation omitted). It is not enough that one skilled in the art could theoretically write a program to achieve the claimed function, rather the specification itself must explain how the claimed function is achieved to demonstrate that the applicant had possession of it. See, e.g., Vasudevan, 782 F.3d at 682–83. If the specification does not provide a disclosure of the computer and algorithm(s) in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention that achieves the claimed result, a rejection under 35 U.S.C. 112(a) for lack of written description must be made. See MPEP § 2161.01, subsection I.
MPEP 2161.01:
I. DETERMINING WHETHER THERE IS ADEQUATE WRITTEN DESCRIPTION FOR A COMPUTER-IMPLEMENTED FUNCTIONAL CLAIM LIMITATION
The 35 U.S.C. 112(a) or first paragraph of pre-AIA 35 U.S.C. 112 contains a written description requirement that is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1344-45, 76 USPQ2d 1724, 1731-32 (Fed. Cir. 2005); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-64, 19 USPQ2d 1111, 1115-16 (Fed. Cir. 1991). Specifically, the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art in a way that shows that the inventor actually invented the claimed invention at the time of filing. Id.;Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172. The function of the written description requirement is to ensure that the inventor had possession of the specific subject matter later claimed as of the filing date of the application relied on; how the specification accomplishes this is not material. In re Herschler, 591 F.2d 693, 700-01, 200 USPQ 711, 717 (CCPA 1979), further reiterated in In re Kaslow, 707 F.2d 1366, 217 USPQ 1089 (Fed. Cir. 1983); see also MPEP §§ 2163 - 2163.04.
The written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, applies to all claims including original claims that are part of the disclosure as filed. Ariad, 598 F.3d at 1349, 94 USPQ2d at 1170. As stated by the Federal Circuit, “[a]lthough many original claims will satisfy the written description requirement, certain claims may not.” Id. at 1349, 94 USPQ2d at 1170-71; see also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1343-46, 76 USPQ2d 1724, 1730-33 (Fed. Cir. 2005); Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1405-06 (Fed. Cir. 1997)(“The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention.”). Problems satisfying the written description requirement for original claims often occur when claim language is generic or functional, or both. Ariad, 593 F.3d at 1349, 94 USPQ2d at 1171 ("The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.").
For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 (“[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.”) (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that “only similar language in the specification or original claims is necessary to satisfy the written description requirement”).
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 “merely by clearly describing one embodiment of the thing claimed.” LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand applicant to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. “[T]he description of one method for creating a seamless DWT does not entitle the inventor . . . to claim any and all means for achieving that objective.” LizardTech, 424 F.3d at 1346, 76 USPQ2d at 1733.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
The level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172; Capon v. Eshhar, 418 F.3d 1349, 1357-58, 76 USPQ2d 1078, 1083-84 (Fed. Cir. 2005). Computer-implemented inventions are often disclosed and claimed in terms of their functionality. For computer-implemented inventions, the determination of the sufficiency of disclosure will require an inquiry into the sufficiency of both the disclosed hardware and the disclosed software due to the interrelationship and interdependence of computer hardware and software. The critical inquiry is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Vasudenvan Sofware, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682. 114 USPQ2d 1349, 1356 (citing Ariad Pharm., Inc. V. Eli Lilly & Co, 598 F.3d 1336, 1351, 94 USPQ2d 1161, 1172 (Fed. Cir. 2010) in the context of determining possession of a claimed means of accessing disparate databases).
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of adequate written description where there were genuine issues of material fact regarding “whether the specification show[ed] possession by the inventor of how accessing disparate databases is achieved”). If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made. For more information regarding the written description requirement, see MPEP § 2162- § 2163.07(b). If the specification does not provide a disclosure of sufficient corresponding structure, materials, or acts that perform the entire claimed function of a means- (or step-) plus- function limitation in a claim under 35 U.S.C. 112(f) or the sixth paragraph of pre-AIA 35 U.S.C. 112, "the applicant has in effect failed to particularly point out and distinctly claim the invention" as required by the 35 U.S.C. 112(b) [or the second paragraph of pre-AIA 35 U.S.C. 112]. In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). A rejection under 35 U.S.C. 112(b) or the second paragraph of pre-AIA 35 U.S.C. 112 must be made in addition to the written description rejection.
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 12-15, 17 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.
Regarding claims 12-15, 17, the features of a control unit configured to renders the claim indefinite due to lacking proper written description. The claimed feature is a nonce term meeting the three prong analysis, but there is no clear corresponding structure disclosed, merely repeating of the nonce term in the disclosure as filed. As such, the claimed feature is rejected under both a and b of 112. MPEP 2181. The dependent claims are rejected for depending on a rejected claim.
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.
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 1-5, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over KR 10-2019-0093941A (herein referred as “Document 1”; cited by Applicant; see Machine Translation) in view of JP 2003260034A (herein referred as “Document 2”; cited by Applicant, see Machine Translation) and Kim et al. (herein referred as “Kim”, WO2019/189970A1 with US 2021/0145297 used as a translation, with using the priority and publishing date of the WO document).
Regarding claim 1, Document 1 teaches a cerebral blood flow measuring device, comprising: a flexible base configured to be deformed correspondingly to a shape of a head in close contact therewith; a plurality of light irradiation units provided on an installation surface, facing the head, of the flexible base; a plurality of light detection units provided on the installation surface (see at least Figures 1-6, and description); a plurality of protrusions provided on the installation surface and formed to protrude at a predetermined height, wherein the plurality of light irradiation units and the plurality of light detection units are each provided at an end portion of respective protrusions of the plurality of protrusion (see at least Figures 1-6); and a plurality of caps each configured to be fixed to one of the plurality of protrusions (interpreted to read on window, see Figures 1-6 and description “At this time, a window is mounted on the upper surface or the upper opening of the support to close the upper opening.”); but does not directly teach an expansion unit configured to deform the flexible base.
Document 2 teaches a related system for wearable sensors, and teaches using a pressurized system to control sensors in contact with skin, which reasonably teaches an expansion unit configured to deform the flexible base (see at least Figures 2-5, and machine translation “Therefore, the sensor member 5 can be brought into close contact with the head by adjusting the pressure of the air sent from the air tank.”). Kim teaches a related system for measuring contact pressure of sensors and scalp for measuring oxy and deoxy levels of hemoglobin, and for correcting errors caused by pressure (see at least [0023], [0047], Figures 2-16; Document 1 includes a pressure sensor). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including an inflation component on a head worn element to expand and allow for sensors to be in closer contact with the head and to measure and account for such pressures in order to increase reliability and accuracy of light measurements from a user’s head.
Regarding claim 2, the limitations are met by Document 1 in view of Document 2 and Kim, where Document 1 teaches wherein the installation surface has the plurality of light irradiation units and the plurality of light detection units arranged (see at least Figures 1-6).
Regarding claim 3, the limitations are met by Document 1 in view of Document 2 and Kim, where the combination teaches wherein as the expansion unit expands, end portions of the plurality of light irradiation units and the plurality of light detection units are configured to come into close contact with the head (see Document 1 Figures 1-6, and Document 2 Figures 2-5, and machine translation “Therefore, the sensor member 5 can be brought into close contact with the head by adjusting the pressure of the air sent from the air tank.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including an inflation component on a head worn element to expand and allow for sensors to be in closer contact with the head in order to increase reliability and accuracy of light measurements from a user’s head.
Regarding claim 4, the limitations are met by Document 1 in view of Document 2 and Kim, where the combination teaches wherein the expansion unit is provided inside the flexible base and is configured to expand the flexible base by receiving pressure from an outside (see Document 1 Figures 1-6, and Document 2 Figures 2-5, and machine translation “Therefore, the sensor member 5 can be brought into close contact with the head by adjusting the pressure of the air sent from the air tank.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including an inflation component on a head worn element to expand and allow for sensors to be in closer contact with the head in order to increase reliability and accuracy of light measurements from a user’s head.
Regarding claim 5, the limitations are met by Document 1 in view of Document 2 and Kim, where the combination teaches the installation surface has a substantially rectangular shape when the expansion unit is not expanded (see Document 1 Figures 1-6, and Document 2 Figures 2-5, and machine translation “Therefore, the sensor member 5 can be brought into close contact with the head by adjusting the pressure of the air sent from the air tank.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including an inflation component on a head worn element to expand and allow for sensors to be in closer contact with the head in order to increase reliability and accuracy of light measurements from a user’s head.
Regarding claim 16, the limitations are met by Document 1 in view of Document 2 and Kim, where Document 1 teaches wherein the light irradiation unit is configured to irradiate light with a wavelength of 700 nm to 900 nm (see Document 1 machine translation).
Regarding claim 17, the limitations are met by Document 1 in view of Document 2 and Kim, where Document 1 teaches wherein a control unit functions to calculate the oxygen saturation of the cerebral blood flow using near-infrared spectroscopy (see Document 1 machine translation).
Claims 6, 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over KR 10-2019-0093941A (herein referred as “Document 1”; cited by Applicant; see Machine Translation) in view of JP 2003260034A (herein referred as “Document 2”; cited by Applicant, see Machine Translation) and Kim et al. (herein referred as “Kim”, WO2019/189970A1 with US 2021/0145297 used as a translation, with using the priority and publishing date of the WO document) as applied to claims 4 and 6 above, and further in view of Gilland (US 2010/0076276)
Regarding claim 6, the limitations are met by Document 1 in view of Document 2 and Kim, where the combination teaches wherein the installation surface is configured to be away from the housing when the expansion unit is expanded (see Document 1 Figures 1-6, and Document 2 Figures 2-5, and machine translation “Therefore, the sensor member 5 can be brought into close contact with the head by adjusting the pressure of the air sent from the air tank.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including an inflation component on a head worn element to expand and allow for sensors to be in closer contact with the head in order to increase reliability and accuracy of light measurements from a user’s head.
However, the limitations of further comprising a housing configured to protect an outermost side of the flexible base opposite the instillation surface are not directly taught.
Gilland teaches a related system for measuring oxygen saturation (see abstract), and teaches that it is known to construct a housing to house oximeter components which reasonably teaches comprising a housing configured to protect an outermost side of the flexible base (see at least [0021]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including oximetry components inside a housing in order to protect the sensor and electronics from damage.
Regarding claim 11, the limitations are met by Document 1 in view of Document 2 and Kim and Gilland, where Gilland teaches further comprising a wearing part connected to one side of the housing or the flexible base and configured to be worn on the head (see at least Figure 2, [0014] headband). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including oximetry sensing components in a headband in order to aid in proper placement on a head of a user.
Regarding claim 12, the limitations are met by Document 1 in view of Document 2 and Kim, where Document 1 teaches calculate oxygen saturation based on light detected by the light detection unit (see title and description) except the limitations of further comprising a control unit configured to control the plurality of light irradiation units and the plurality of light detection units are not directly taught.
Gilland teaches a related system for measuring oxygen saturation (see abstract), and teaches that it is known to include a control unit configured to control the plurality of light irradiation units and the plurality of light detection units, and calculate oxygen saturation based on light detected by the light detection unit (see at least [0024], [0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including oximetry controls in components for sensing in order to properly measure oxygen saturation using desired wavelengths.
Regarding claim 13, the limitations are met by Document 1 in view of Document 2 and Kim and Gilland, where Gilland teaches further comprising a display unit configured to be recognized by a person by sight (see at least Figure 2, 5, [0034]).
Regarding claim 14, the limitations are met by Document 1 in view of Document 2 and Kim and Gilland, where Gilland teaches wherein when the oxygen saturation is greater than or equal to a predetermined threshold value, the control unit controls the display unit to display the oxygen saturation (contingent situation, and control unit claimed as an intended use such that it is capable of operating when such situation is occurring, is reasonably taught by Gilland Figure 2 as any value is displayed, so a predetermined value of 0 is any number shown above 0 to be capable of the intended use).
Regarding claim 15, the limitations are met by Document 1 in view of Document 2 and Kim and Gilland, where the combination teaches further comprising a pressure sensor configured to measure the pressure between the light irradiation unit and the light detection unit and the head surface, wherein the control unit performs calculations to correct the oxygen saturation based on a value measured from the pressure sensor (see document 1 pressure sensor, see Kim at least [0023], [0047], Figures 2-16). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including an inflation component on a head worn element to expand and allow for sensors to be in closer contact with the head and to measure and account for such pressures in order to increase reliability and accuracy of light measurements from a user’s head.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over KR 10-2019-0093941A (herein referred as “Document 1”; cited by Applicant; see Machine Translation) in view of JP 2003260034A (herein referred as “Document 2”; cited by Applicant, see Machine Translation) and Kim et al. (herein referred as “Kim”, WO2019/189970A1 with US 2021/0145297 used as a translation, with using the priority and publishing date of the WO document) as applied to claim 4 above, and further in view of Lash et al. (Lash, US 11,944,432).
Regarding claim 7, the limitations are met by Document 1 in view of Document 2 and Kim, except the limitations of wherein the plurality of light detection units are provided in greater numbers than the plurality of light irradiation units are not directly taught.
Lash teaches a related system for measuring oxygen saturation (see title and abstract), and teaches that such sensors can be customized to have any number of sources and detectors as desired to measure oxygen saturation of tissue, which reasonably teaches wherein the plurality of light detection units are provided in greater numbers than the plurality of light irradiation units (see at least col. 13 lines 6-15 “Further, there may be any combination of detector structures and source structures and the number of detector structures need not equal the number of source structures. For instance, if there are three openings, there may be one detector structure and two source structures or two detector structures and one source structure. As another example, if there are eight openings, there may be two detector structures and six source structures, five detector structures and three source structures, or four detector structures and four source structures.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including more sensors than sources in a device to measure oxygen saturation as desired by a user.
Regarding claim 8, the limitations are met by Document 1 in view of Document 2 and Kim, except the limitations of wherein the plurality of light irradiation units are provided in greater numbers than the plurality of light detection units are not directly taught.
Lash teaches a related system for measuring oxygen saturation (see title and abstract), and teaches that such sensors can be customized to have any number of sources and detectors as desired to measure oxygen saturation of tissue, which reasonably teaches wherein the plurality of light irradiation units are provided in greater numbers than the plurality of light detection units (see at least col. 13 lines 6-15 “Further, there may be any combination of detector structures and source structures and the number of detector structures need not equal the number of source structures. For instance, if there are three openings, there may be one detector structure and two source structures or two detector structures and one source structure. As another example, if there are eight openings, there may be two detector structures and six source structures, five detector structures and three source structures, or four detector structures and four source structures.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including more sensors than sources in a device to measure oxygen saturation as desired by a user.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims filed 5/27/2026.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112(a) have been fully considered but are not persuasive. Applicant argues that the claims are directed to a computer implemented claims. The examiner respectfully disagrees. The claims use the term “control unit” which is a nonce term to implement functional limitations as addressed in the claim interpretation. There is no reference to any computer in the disclosure as filed. As discussed in MPEP 2181:
“With respect to the first prong of this analysis, a claim element that does not include the term “means” or “step” triggers a rebuttable presumption that 35 U.S.C. 112(f) does not apply. When the claim limitation does not use the term “means,” examiners should determine whether the presumption that 35 U.S.C. 112(f) does not apply is overcome. The presumption may be overcome if the claim limitation uses a generic placeholder (a term that is simply a substitute for the term “means”). The following is a list of non-structural generic placeholders that may invoke 35 U.S.C. 112(f): “mechanism for,” “module for,” “device for,” “unit for,” “component for,” “element for,” “member for,” “apparatus for,” “machine for,” or “system for.”Welker Bearing Co., v. PHD, Inc., 550 F.3d 1090, 1096, 89 USPQ2d 1289, 1293-94 (Fed. Cir. 2008); Mass. Inst. of Tech. v. Abacus Software, 462 F.3d 1344, 1354, 80 USPQ2d 1225, 1228 (Fed. Cir. 2006); Personalized Media, 161 F.3d at 704, 48 USPQ2d at 1886–87; Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1214-1215, 48 USPQ2d 1010, 1017 (Fed. Cir. 1998). Note that there is no fixed list of generic placeholders that always result in 35 U.S.C. 112(f) interpretation, and likewise there is no fixed list of words that always avoid 35 U.S.C. 112(f) interpretation. Every case will turn on its own unique set of facts.”
“If there is no disclosure of structure, material or acts for performing the recited function, the claim fails to satisfy the requirements of 35 U.S.C. 112(b). The disclosure of the structure (or material or acts) may be implicit or inherent in the specification if it would have been clear to those skilled in the art what structure (or material or acts) corresponds to the means- (or step-) plus-function claim limitation. See id. at 1380, 53 USPQ2d at 1229; In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir. 1997). However, “[a] bare statement that known techniques or methods can be used does not disclose structure” in the context of a means plus function limitation. Biomedino, LLC v. Waters Technology Corp., 490 F.3d 946, 952, 83 USPQ2d 1118, 1123 (Fed. Cir. 2007) (Disclosure that an invention “may be controlled by known differential pressure, valving and control equipment” was not a disclosure of any structure corresponding to the claimed “control means for operating [a] valving ” and the claim was held indefinite). See also Budde v. Harley-Davidson, Inc., 250 F.3d 1369, 1376, 58 USPQ2d 1801, 1806 (Fed. Cir. 2001); Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 296 F.3d 1106, 1115-18, 63 USPQ2d 1725, 1731-34 (Fed. Cir. 2002) (Court interpreted the language of the “third monitoring means for monitoring the ECG signal…for activating …” to require the same means to perform both functions and the only entity referenced in the specification that could possibly perform both functions is the physician. The court held that excluding the physician, no structure accomplishes the claimed dual functions. Because no structure disclosed in the embodiments of the invention actually performs the claimed dual functions, the specification lacks corresponding structure as required by 35 U.S.C. 112, sixth paragraph, and fails to comply with 35 U.S.C. 112, second paragraph.).”
“See also, Blackboard, Inc. v. Desire2Learn, Inc., 574 F.3d 1371, 1382-83, 91 USPQ2d 1481, 1490-91 (Fed. Cir. 2009) (concluding that the description of a server computer’s “access control manager” software feature was insufficient disclosure of corresponding structure to support the computer-implemented “means for assigning” limitation because “what the patent calls the ‘access control manager’ is simply an abstraction that describes the function of controlling access to course materials … [b]ut how it does so is left undisclosed.”); Aristocrat, 521 F.3d at 1334-35, 86 USPQ2d at 1240 (explaining that “the [patent’s] description of the embodiments is simply a description of the outcome of the claimed functions, not a description of the structure, i.e., the computer programmed to execute a particular algorithm”).”
“When a claim containing a computer-implemented 35 U.S.C. 112(f) claim limitation is found to be indefinite under 35 U.S.C. 112(b) for failure to disclose sufficient corresponding structure (e.g., the computer and the algorithm) in the specification that performs the entire claimed function, it will also lack written description under 35 U.S.C. 112(a). See MPEP § 2163.03, subsection VI. Examiners should further consider whether the disclosure contains sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the full scope of the claimed invention in compliance with the enablement requirement of 35 U.S.C. 112(a). See MPEP § 2161.01, subsection III, and MPEP § 2164.08.”
As the disclosure does not clearly identify the corresponding structure, but merely repeats the nonce term, the claims are rejected under 112(a) and (b).
In addition, there is no algorithm disclosed for the claim 15 recited functions in addition to the structural issues raised above. The disclosure merely repeats that such action can be taken without any algorithm or explanation as to how the pressure is used to correct the oxygen saturation.
The rejections are respectfully maintained.
Applicant’s arguments regarding the rejection of the claims under 35 U.S.C. 112(b) have been fully considered and are partially persuasive due to the amendments to the claims; the rejections remain as presented above.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered but are not persuasive in view of the new grounds of rejections necessitated by amendments to the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant’s amendments into the independent claims of new features of plurality of caps are reasonably taught by the windows fixed to the protrusions of Document 1. The rejections are respectfully maintained as presented above to account for the amendments to the claims.
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 MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
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