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 .
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.
Election/Restrictions
Applicant’s election of Group II in the reply filed on 03 October 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant has not pointed out the supposed errors in the restriction requirement. For example, Applicant has not set forth why the Groupings are not independent or distinct from each other or why the Groupings are in fact obvious variants. Applicant states “The two main features of the elected invention are ‘sensors’ and ‘dressing’. These two words do not coincide together in either subclass representing a novel and non-obvious invention.” This does not address the independent or distinct standard presented in the Restriction Requirement of 31 July 2025. It is noted that the specific terms of “sensors” and “dressing” do not need to be present in the subclass wording for the claims to be appropriately classified in that area. Additionally, it is noted that no determination on allowability was made in the Restriction Requirement of 31 July 2025 and any reciting of the words “not obvious” was with respect to the inventions being not obvious variants.
Applicant has withdrawn claims 1-4, 6, 16, 18-19, amended claims 5, 7-15, 17, 20, and added claims 21-27. Amended claims 5, 8-15, 17 and 20 as well as new claims 21, 26 and 27 have additionally been withdrawn by the Examiner as being directed to non-elected subject matter.
Claims 9, 5, 8, 10-15, 17, 20, 27 and 26 are independent and distinct from elected Group II because they are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP 806.05(j). In the instant case, the invention as claimed have a materially different design (non-thermal, i.e. only sensing), mode of operation (non-thermal, i.e. only sensing) and effect (non-thermal, i.e. only sensing). Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing showing them to be obvious variants.
Claims 7 and 22-25 have been examined below.
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.
Claim(s) 23, 7, 22, 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0146883 A1 to Sansone (Sansone) in view of US 2009/0198311 A1 to Johnson et al. (Johnson) and US 2008/0234788 A1 to Wasowski (Wasowski).
Regarding claim 23, Sansone teaches a conformable thermal therapeutic dressing with sensors (Fig. 10) comprising a containment pack (containment pack 1) has an inner layer (side with the sensors as seen in Fig. 10) closed to the skin and an outer layer (side opposite the side with the sensors as seen in Fig. 10) further from the skin, said inner layer has sensors (biosensors 8) located thereon, said sensors are connected to a multiplexer ([0058] which states in part “Biosensor port 48 may include a multiplexer.”) with sensor circuitry and/or data transmission (biosensor wires 28), and said containment pack has a preloaded first material ([0041] which states in part “Containment pack 1 is fillable with thermally treatable material.”) preplaced to create a chemical thermal reaction (abstract which states “Wearable thermal device comprises: at least one containment pack of selected shape; containment pack(s) contains a selected amount of first material (preloaded component); at least one port is attached to containment pack(s) configured to accept a second material (second component); and said second material is added through said at least one port to create a chemical reaction when combined with said first material.”).
However, Sansone is silent with respect to said containment pack having at least one volume deflector configured to provide areas of positive and negative curvature, locating the sensors on the areas of positive curvature and the sensor circuitry and/or data transmission being generally co-located with said negative curvature.
Johnson teaches an analogous device (see for example Fig. 3) to that of Sansone as well as wherein said containment pack (cooling blanket 100) has at least one volume deflector (seams as shown in Fig. 3 and discussed with respect to reference number 180 in Fig. 1) configured to provide areas of positive and negative curvature (inherent in that the seams join the outside layer 110 and the inside layer 120 together to form compartments 170 which contain reagent 101). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sansone with the multi compartment configuration of Johnson to prevent migration of the reagent as taught by Johnson ([0037] which states in part “each compartment 170 is configured with at least one one-way valve 200 to create a network that provides one-way, fluid communication through multiple compartments 170.) which will allow for a more even distribution of the cooling throughout the device.
Wasowski teaches an analogous segmented cooling dressing (see for example Fig. 3) where sensors (50, Figs. 8-10) are in communication with a control unit (14) by means of leads (58) and all positioned to be in communication with the skin of the user ([0097] which states in part “Sensors 50 are in communication with cooling and grounding unit 14 by means of leads 58. In a preferred embodiment, all of sensors 50 are in contact with the skin of body 18…”). The sensors are located in an area of positive curvature (see location of 50 in Figs. 9 and 10). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have located the sensors as taught by Wasowski to allow for the sensors to all be in communication with the skin of the body as taught by Wasowski.
Regarding claim 7, the combination teaches the dressing of claim 23 as well as Johnson teaching wherein said inner layer is a molded composite layer ([0034] which states in part “The inside layer 120 may also include any convenient sub-layers.”) with voids and channels (area between adjacent compartment 170 formed by seams 180) having absorbent material ([0034] which states in part “For example, a sub-layer may be constructed of a material that is suitable for being placed in direct contact with a mammal (e.g., with the mammals skin); for example, non-tearing paper or cotton type may provide a comfortable surface for the mammal…Multiple sub-layers may be constructed of the same materials; for instance, the inside layer 120 may include multiple sub-layers of one or more types of non-tearing paper or cotton and/or multiple sub-layers of one or more types of pliable plastic and/or one or more types of insulating material.”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sansone with the configuration of the inner layer of Johnson to allow for a comfortable surface to be applied to the skin of the user as taught by Johnson.
Regarding claim 22, the combination teaches the dressing of claim 22 as well as Johnson teaching wherein said inner layer has absorbent material in areas of negative curvature ([0034] which states in part “For example, a sub-layer may be constructed of a material that is suitable for being placed in direct contact with a mammal (e.g., with the mammals skin); for example, non-tearing paper or cotton type may provide a comfortable surface for the mammal…Multiple sub-layers may be constructed of the same materials; for instance, the inside layer 120 may include multiple sub-layers of one or more types of non-tearing paper or cotton and/or multiple sub-layers of one or more types of pliable plastic and/or one or more types of insulating material.” Paper and cotton are absorbent materials and located as claimed since they make up the inner layer which includes the areas of negative curvature). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sansone with the configuration of the inner layer of Johnson to allow for a comfortable surface to be applied to the skin of the user as taught by Johnson.
Regarding claim 24, the combination teaches the dressing of claim 23 as well as Sansone teaching wherein said sensors are spatially referenced for three dimensional representation of data from sensed measurements ([0027] which states in part “An example is a wearable device consisting of a single layer of multiple PPG sensors with the intent to measure in a 3 dimensional (3D) analysis: blood flow; blood pressure; cellular pressure; and/or oxygen levels of appendage or body part. Other advantages include, but not limited to: creation of a 3D volume; images; and/or video for detailed observation of appendage or body part function.”).
Regarding claim 25, the combination teaches the dressing of claim 23 as well as wherein said sensors are at least one type of sensor ([0027] which states in part “It is the intent of the current invention to provide onboard sensors….Examples include but not limited to: temperature sensors for the device connected and unconnected; sensors to measure temperature of the appendage and/or body part; electrical sensors as in EEG electroencephalogram; and or optical sensors as in PPG, photoplethysmography.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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, Linda Dvorak can be reached at (571)272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAITLYN E SMITH/Primary Examiner, Art Unit 3794