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 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.
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.
Claim(s) 1-2, 7-9, 12-13, and 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150182121 A1 by Barbour et al. (hereafter Barbour, previously of record) further in view of US 20070287897 A1 by Faris (hereafter Faris, previously of record) and further in view of US 20190150526 A1 by Lehna et al. (hereafter Lehna, previously of record).
Regarding claims 1-2, 12-13, and 16 Barbour teaches: 1. A bra for optical detection of abnormal breast tissue (se Barbour’s Abstract) comprising:
a cup which is configured to be worn on a person's breast; [[wherein the cup includes a proximal portion; wherein the cup includes a distal portion, wherein the proximal portion is configured to be closer to the person's chest wall than the distal portion the cup is worn on the person's breast]] (see Barbour’s Fig. 5 noting cups 100R and 100L sized and shaped to accommodate a left and right breast respectively, from there note that the apex of the cup is a distal portion and the circumference of the cup is the proximal portion, with the portion indicated in brackets being removed from the claim but still relevant to dependent claims and therefore still included herein), and …
… a virtual plane which passes through the cup … (regarding the virtual plane, while these limitations appear to be inherent as the plane could be any arbitrary plane and as something that is “virtual” does not require any structure. However, the examiner notes for compact prosecution purposes, including for the modification below, that Barbour has specific and meaningful imaging planes that could serve as the virtual plane. Specifically each cup is sections into quarter Q1-4 and two of these contain emitters and the other two of them contain receivers to allow for imaging through/across the breasts along specific planes, see the two dashed lines separating the quadrants Q1-4 in Fig. 5 or simply see Barbour’s [0057]-[0062] which describes as much as Barbour has two imaging planes that can be the virtual planes at issue across which Barbour would perform imaging);
an array of light emitters, … and an array of light receivers (see Fig. 5 parts 110 are myriad and which can be variously arranged in arrays on the quadrants as per [0057]-[0062] which also describe that they emit or receive light, with further description of the structures being provided in [0066] which iterates that these can be either optical fibers or LEDs/photodiodes), …
wherein changes in light emitted from the light emitters and received by the light receivers which are caused by interaction between the light and the breast (the examiner notes that this is a desideratum about the applicant’s preferred/intended use and not a limitation on the structure of the emitters or receivers and as such can be interpreted as holding no patentable weight or otherwise as inherent. While not required to properly reject the claim, the examiner notes that it may compact prosecution to see that as per Fig. 5 the emitters are receivers are arranged so that this will occur in use an/or see Fig. 1 which is a breast image gathered from the emitted and received light) are analyzed to detect abnormal breast tissue (the examiner notes that the claim does not contain a structure configured to perform an analysis (e.g. a processor) so from a first perspective this can likewise be treated as a second desideratum about how the applicant intends/prefers the received light to be utilized and thus can be treated as holding no patentable weight or otherwise as inherent. However, and for compact prosecution purposes the examiner notes Barbour’s Fig. 1 shows that such an analysis is conducted and/or Barbour’s [0064]-[0065] describes a computing means and processing for tumor detection).
In the foregoing the examiner omitted, as indicated by ellipsis, several limitations including all limitations about the expandable chambers because while Barbour teaches the basic invention including having multiple imaging planes of particular interest, Barbour alone fails to teach the use of expandable chambers and thus fails to teach each of: “a first set of one or more expandable chambers on a first side of a virtual plane which passes through the cup;” or “a second set of one or more expandable chambers on a second side of the virtual plane;” or “wherein at least some of the light emitters are configured to be between the first set of one or more expandable chambers and the breast;” or “wherein at least some of the light receivers are configured to be between the second set of one or more expandable chambers and the breast;”.
However, Faris in the same or eminently related field of optical imaging to detect breast cancer (see Faris’s Abstract) teaches that one should compress the breast along an optical imaging axis and that this is advantageous (see Faris’s [0074] which iterates that compression decreases the total distance the light travels through the breast thus increasing SNR which is the primary motivation to enact such mild compression, though there are at least two other advantages in that this reduces the pain of compression and/or allows for the resultant optical image to be compared to mammography images taken under compression as per [0038] and [0073]-[0074]).
Therefore it would have been obvious to one of ordinary skill in the art prior to the date of invention to modify the bra of Barbour to at least mildly compress the breast along the imaging axes used by Barbour in order to advantageously increase the SNR of the received optical signal among other benefits iterated above.
However the combination of Barbour IVO Faris would only teach “a first set of one or more [compression means] on a first side of a virtual plane which passes through the cup;” or “a second set of one or more [compression means] on a second side of the virtual plane;” or “wherein at least some of the light emitters are configured to be between the first set of one or more [compression means] and the breast;” or “wherein at least some of the light receivers are configured to be between the second set of one or more [compression means] and the breast;”. Because Faris fails to teach that the means to provide the compression should be “expandable chambers” per se so as to only teach a genus of the claimed species and because Barbour IVO Faris do not regard the relative flexibility of the distal and proximal portions they would also fail to teach “wherein the distal portion is more flexible or elastic than the proximal portion” as well as the various limitations of dependent claims 2, 12-13, and 16 which relate to the expandable chambers and bra design.
However Lehna in the same related field of smart bras for breast cancer detection (see Lehna’s Abstract for establishing that this is a smart bra in general, but note also that this is meant to integrate biosensors for breast cancer detection as per [0099]-[0102]), teaches [claim 1] that one can use one or more expandable members to move or compress the breast (see e.g. Lehna’s Figs. 10-14 for a general view of expandable chambers and 16-17 showing the expandable chambers of the bra particularly or see Fig. 15A showing the chambers as mounted within the bra, then see Lehna’s [0079] which describes that the chambers can have plural sub-chambers as well as noting that the singular includes the plural as per Lehna’s [0070], though regardless this would teach using at least one or more chambers on each side of the axis of compression given by Faris, as for their affect being to move or shape or compress breast tissue, this is both something that an expandable chamber is inherently fully capable of but can also be expressly seen in Lehna’s [0084] where the force/pressure of the chambers can be varied to specifically shape the breast) and [claim 16] wherein the cup includes a proximal portion and a distal portion, wherein the proximal portion is configured to be closer to the person's chest wall than the distal portion (this describes the inherent structure of a bra cup, but for compact prosecution purposes see e.g. the rejection of this feature by Barbour above or see Lehna’s Figs. 8-9 noting this is a bra having cups), and wherein the distal portion is more flexible or elastic than the proximal portion (Lehna teaches that the bra can be constructed after a variety of popular styles and thus can have an underwire to reinforce the proximal portion so as to make it more rigid/less flexible than the distal portion, see e.g. [0055] and [0081]) and [claim 2] wherein expandable chambers are expanded by being filled with a flowable substance [claims 3-4] which can be a liquid or gas (see Lehna’s [0077] which directly states as much and covers both liquids and gasses) and [claim 12] wherein each expandable chamber is connected to a separate tube and [claim 9, partial] can be expanded more or less than the other chambers (being expandable to a more-or-less degree is inherently something that an expandable chamber is fully capable of, but for compact prosecution the examiner notes that Lehna addresses that these chambers and sub-chambers can be separately inflated by any desired amount to shape the breast as per [0084] in light of [0087] and claim 10 which show that this can be accomplished using multiple sub-chambers where the fluid is specifically and selectively moved into or out of them to that end. Likewise, if the chambers can be selectively inflated then they necessarily have their own tubing, as elsewise they could only be collectively inflated which is contrary to Lehna’s teachings) and [claim 13] can have undulating, variable-width sections along its length (this is depicted in Lehna’s Figs. 10-14 and 16-17 but also discussed in e.g. [0088]). Motivation to employ the teachings of Lehna can come from multiple places including Faris or Lehna itself which shows the advantages of such modifications (first and most basically see MPEP 2144.07 where Faris, utilized above, would require two opposing means to enact compression of the breast but does not set forth the structure of any compression means that can be employed in a bra of the sort employed by the base reference of Barbour, but Lehna shows a suitable arrangement for enacting this same compression and therefore would be a suitable means to achieve the advantage of Faris, e.g. the improved SNR of imaging through a compressed breast. Secondly Lehna also states why this sort of arrangement for reshaping the breast is advantageous, see e.g. [0003]-[0004] as well as [0006] and [0094] wherein Lehna’s way of enacting this shaping/compressing is done so as to minimize discomfort which is a further advantage to employing Lehna’s teachings instead of another inflatable bra to enact Faris’s teachings and/or teaches that the invention has additional utility, e.g. allowing the user to improve their self-confidence by selectively shaping the breasts in other ways when not being used for imaging).
Therefore it would have been obvious to one of ordinary skill in the art prior to the date of invention to improve the combination of Barbour and Faris addressed above with the structures for breast shaping taught by Lehna in order to advantageously use a suitable and known configuration to enact the compression of Faris and/or to advantageously enact such compression in a way that minimizes patient discomfort as taught by Lehna and/or because this advantageously provides additional utility such as the ability to shape the breasts in ways that increase the user’s self-confidence as taught by Lehna.
Regarding claim 7, Barbour further teaches: 7. The bra in claim 1 wherein the proximal portion has a ring, band, column-section, or frustal shape (see Barbour’s Fig. 5 or, for a side perspective Fig. 4, where when regarding the proximal portion (e.g. cut in half at a plane half-way between the proximal perimeter and the apex) the shape would be a ring/band/column is depicted in Fig. 4 or a conical frustrum as depicted in Fig. 5 (or Fig. 4 if cut further towards the apex than a halfway point), though for compact prosecution purposes the examiner notes that Lehna also appears to teach these same sorts of shapes).
Regarding claim 8, Barbour further teaches: 8. The bra in claim 1 wherein a proximal perimeter of the proximal portion has a circular, elliptical, oval, teardrop, or crescent shape (see Barbour’s Fig. 5, at the exact proximal end/perimeter this is a teardrop shape due to the spike/extension at the attachment points of the strap, though for compact prosecution purposes the examiner notes that Lehna also appears to teach other of the various options listed).
Regarding claim 9, the examiner notes that Barbour IVO Faris and Lehna teaches the base invention as give above in regards to claim 1, and the examiner also specifically iterated above in that rejection how the modification to utilize the teachings of Lehna would address portions of the claim such as having multiple chambers that can selectively be expandable to varying degrees of expansion (see rejection above for all details or see Lehna’s [0084] in light of [087] or claim 10 for a quick overview, noting that this selective shaping can utilize “one or more” chambers or two chambers) such that the combination teaches all limitations of the claims except that there are three chambers, with Lehna instead teaching a plurality of chambers but never directly stating that the plurality could be three.
However, the examiner notes that this is prima facie obvious over the teachings of Lehna for at least two reasons. First, simply duplicating the same element for the same purpose to arrive at additional expandable chambers is addressed in MPEP 2144.04(VI)(B). Second the range or number of expandable chambers of the prior art both overlaps (i.e. one or more overlaps the claimed three) and is similar/approaches (i.e. two is a similar amount to three) the claimed range in the manner addressed in MPEP 2144.05(I).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the date of invention to employ three expandable chambers as the one or more expandable chambers taught by the prior art, at least in light of the legal precedent provided by MPEP 2144.
Regarding claims 17 and 20-22, Barbour IVO Faris and Lehna teaches the basic invention as given above in regards to claim 1 and Lehna further teaches: 17. The bra in claim 1 wherein areas of the cup which are closer to the virtual plane are more flexible or elastic than other areas of the cup. 20. The bra in claim 1 wherein a first side of an expandable chamber of the one or more expandable chambers which faces toward the virtual plane is thinner than a second side of the expandable chamber which faces away from the virtual plane. 21. The bra in claim 1 wherein a first side of an expandable chamber of the one or more expandable chambers which faces away from a perimeter of a cup is more elastic than a second side of the expandable chamber which faces toward the perimeter of the cup. 22. The bra in claim 1 wherein a first side of an expandable chamber of the one or more expandable chambers which faces away from a perimeter of a cup has a lower Young's modulus than a second side of the expandable chamber which faces toward the perimeter of the cup (regarding each of these, see Lehna’s [0079] noting that the inner layer of the expandable chamber is made of ultra-soft silicone and the outer layer is made of standard silicone such that the layer facing/comprising the contact of the virtual plane/contact with the breast is made of a softer and more flexible material than the outer layer/layer facing or closer to the perimeter of the cup. For compact prosecution purposes the examiner notes that the foregoing appears to teach that these layers are explicitly on either side of the expandable chamber but it is also noteworthy that this would be a portion of the combination regardless as in Barbour the light receivers and emitters must be able to access the breast tissue in order to function so they must still be the innermost layer in the modification, something also indicated in Lehna at [0100]. To additionally compact prosecution, the examiner further notes that additional documentation regarding stiffness/flexibility and their relationship to Young’s modulus has been made of record to further clarify why the examine regards ultrasoft silicone as being more flexible and having a lower young’s modulus than standard silicone).
Regarding claims 18-19, Barbour IVO Faris and Lehna teaches the basic invention as given above in regards to claim 1; however, none of these references describe the extent of the expandable chambers with respect to the perimeter of the cup nor the shapes of the expandable chambers and as such the references fail to explicitly teach: “18. The bra in claim 1 wherein the one or more expandable chambers collectively span between 60% and 85% of the perimeter of the cup.” And “19. The bra in claim 1 wherein an expandable chamber of the one or more expandable chambers has a crescent or banana shape.”
However, the examiner notes that in both instances that merely changing the shape, size, or proportion of the expandable chambers would cause the teachings of Lehna to read on the claims, and that these sorts of changes are addressed by MPEP 2144.04(IV) as being prima facie obvious variants. More specifically, changing the size or proportion of Lehna’s expandable chambers such that they covered 60-85% of the perimeter of the cup from and unknown proportion of the perimeter of the cup and/or changing the shape of the expandable portion from and undefined shape to a crescent or banana shape would be an obvious variant under the legal precedent provided by MPEP 2144.04(IV)(A)-(B).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the date of invention to re-size or re-shape the one or more expandable chambers taught by the prior art to make them cover the claimed portion of the perimeter or conform to the claimed shape, at least in light of the legal precedent provided by MPEP 2144.
Regarding claim 23, Barbour IVO Faris and Lehna teaches the basic invention as given above in regards to claim 1 and Lehna further teaches: 23. The bra in claim 1 wherein the one or more expandable chambers are expanded by a pump which is operated by the person wearing the bra so that the person can easily stop expansion to avoid pain from over-compression (Lehna’s teaches at various places that the pumps are configured to receive user input and selectively inflate or deflate as desired with e.g. [0083] being exemplary as it covers that the user can selectively inflate or deflate the expandable chambers, but with any of [0087], [0097]-[0098], [0104], [0107] etc. each having relevant teachings. For compact prosecution purposes the examiner notes that references relating to manual pumps, not currently under examination, are already of record in parent application 18/237231).
Response to Arguments
Applicant’s arguments, see page 1, filed 10/26/2025, with respect to the 101 rejection have been fully considered and are persuasive. The associated rejection of the previous office action has been withdrawn.
Applicant's arguments filed 10/26/2025 with respect to the 103(a) rejection under Barbour, Faris, and Lehna have been fully considered but they are not persuasive as follows:
As an initial matter, the arguments are convincing/moot for all cancelled claims.
On page 1 the applicant addresses claims 1-15 and notes the amendment. In this instance the examiner does not regard the amendment as overcoming the prior art rejection for the non-cancelled claims for the reasons iterated above and notes that the applicant does not lodge specific arguments are address specific defects in the claims. Therefore, the argument is not convincing to remove the previously issued rejection.
On pages 1-2 the applicant opines that the subject matter of new claims 16-23 are supported by the specification and are not taught by the prior art. While the examiner agrees that the applicant has identified support for their amendments, and while the examiner has had to issue new grounds of rejection to cover these new claims, the examiner is not convinced that the subject matter is not taught by the combination of Barbour, Faris, and Lehna (re: claims 17 and 20-23) or not an obvious variant of what is taught therein (re: claims 18-19) for the reasons given above in the new grounds of rejection which are incorporated herein to fully rebut these assertions. Therefore, the argument is not fully conniving and a rejection utilizing the same prior is maintained above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
Young’s modulus and Stiffness, both by Wikipedia, are two simple background reference for establishing the basic meaning of Young’s modulus and describing how it relates to other physical properties such as stiffness and elasticity. As such these references are useful in understanding the examiner’s position taken in regards to claims 17 and 20-22.
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 S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL S KELLOGG/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798