Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 25 and 32 are objected to because of the following informalities:
Regarding claim 25, “the” should be in between “causes” and “output” in “which causes output device to produce”.
Regarding claim 32, in the last line, “[see paragraph 0036 of the PCT Application]” should be deleted.
Appropriate correction is required.
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.
Claim 29-31 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 29-31, claim 29 is dependent on claim 11, claim 30 is dependent on claim 12, and claim 31 is dependent on any one of claims 11-13. This renders claims 29-31 indefinite as claims 11-13 have been cancelled. It is unclear what claims 29-31 are dependent on. The Examiner will interpret the claims to be dependent upon claim 1.
Claim Rejections - 35 USC § 103
Claims 1-3, 5-10, 14-16, 18, 19, 21, 23, and 25-32 are rejected under 35 U.S.C. 103 as being unpatentable over Baeuerle (WO 2019148047 A1) in view of Gabriel et al. (State of the art opioid-sparing strategies for post operative pain in adult surgical patients), submitted as an IDS on 03/20/2023).
Regarding claim 1, Baeuerle teaches a combinatorial therapeutic system (“combinatorial therapeutic systems can include an opioid analgesic and an artificial sensory experience”, abstract), comprising:
A systemic, centrally and peripherally acting analgesic (“includes a centrally and/or peripherally acting analgesic”, paragraph [0004]);
An artificial sensory experience generator that includes a processor and computer-readable memory, the artificial sensory experience generator configured to implement an artificial sensory experience comprising one or more of 2D artificial sensory experience, 3D artificial sensory experience, 4D artificial sensory experience, holography, augmented reality, virtual reality, or mixed reality (“can be combined with an artificial sensory experience…or mixed reality”, paragraph [0004]); and
An output device configured to produce sensory stimuli representative of a patient’s symptom (“output device to produce sensory stimuli representative of the symptom”, paragraph [0038]; output device 112, symptom 120, Fig. 1),
Wherein the artificial sensory experience comprises a virtual representation of the patient’s symptom (“output device can provide a virtual representation of the symptom”, paragraph [0043]; output device 112, symptom 120, Fig. 1), wherein the symptom includes pain.
Baeuerle does not teach the analgesic being selected from bupivacaine-meloxicam.
However, Gabriel et al. teaches the acting analgesic being selected from bupivacaine-meloxicam (“once HTX-011 is administered directly into the surgical wound, the polymer undergoes a steady hydrolysis that releases bupivacaine and meloxicam slowly over 3 days”, page 7, left col, paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Baeuerle with the bupivacaine-meloxicam of Gabriel et al. as an analgesic in order to provide lasting relief for chronic pain in patients, as well as address both physical and psychological components of chronic pain.
Regarding claim 2, a modified combinatorial therapeutic system of Baeuerle in view of Gabriel et al. teaches all the limitations of claim 1.
Furthermore, Gabriel et al. teaches the analgesic comprising of oliceridine (“currently in development that may prove to be a significant advance over existing mu opioid receptor agonists…is Olicderidine”, page 7, right col, paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Baeuerle in view of Gabriel et al. and use oliceridine as an analgesic for the combinatorial therapeutic system to treat and mitigate chronic pain.
Regarding claim 3, a modified combinatorial therapeutic system of Baeuerle in view of Gabriel et al. teaches all the limitations of claim 1.
Furthermore, Gabriel et al. teaches the analgesic comprising of bupivacaine-meloxicam (“once HTX-011 is administered directly into the surgical wound, the polymer undergoes a steady hydrolysis that releases bupivacaine and meloxicam slowly over 3 days”, page 7, left col, paragraph 3).
Regarding claim 5, Baeuerle in view of Gabriel et al. teaches the artificial sensory experience comprising virtual reality distraction therapy (“the artificial sensory experience is virtual reality as applied in virtual reality distraction therapy”, paragraph [0050]).
Regarding claim 6, Baeuerle in view of Gabriel et al. teaches the artificial sensory experience comprising virtual reality neuropsychological therapy (VRNT) (“the artificial sensory experience is virtual reality, preferably VRNT”, paragraph [0008]).
Regarding claim 7, Baeuerle in view of Gabriel et al. teaches the VRNT comprising a 4D sensory experience that is implemented as a 3D visual stimulus and at least one additional sensory stimulus selected from auditory, tactile, olfactory, and gustatory (“the VRNT comprises a 4D sensory experience…and gustatory”, claim 8).
Regarding claim 8, Baeuerle in view of Gabriel et al. teaches a 3D sensory experience selected from a 3D visual stimulus or a 2D visual stimulus and at least one additional sensory stimulus selected from auditory, tactile, olfactory, and gustatory (“a 3D sensory experience selected from a 3D visual stimulus…gustatory”, claim 9).
Regarding claim 9, Baeuerle teaches the system further comprising a 2D visual sensory stimulus (“system can include a 2D visual display having one or more additional, non-visual stimuli associated”, paragraph [0045]).
Regarding claim 10, Baeuerle teaches a method for treating and/or mitigating pain in a patient (“methods for treating and/or mitigating pain”, paragraph [0005]), comprising:
The patient receiving a systemic, centrally and peripherally acting analgesic;
The patient receiving an artificial sensory experience (“combines administration of an analgesic and an artificial sensory experience to a patient”, paragraph [0013]; Fig. 1) comprising one or more of 2D artificial sensory experience, 3D artificial sensory experience, 4D artificial sensory experience, holography, augmented reality, virtual reality, or mixed reality (“can be combined with an artificial sensory experience…or mixed reality”, paragraph [0004]); and
The patient receiving sensory stimuli representative of a symptom,
Wherein the artificial sensory experience comprises a virtual representation of the symptom (“can produce, for example, visual and/or other sensory stimuli to allow a patient to virtually experience their symptom”, paragraph [0037]), wherein the symptom includes pain.
Baeuerle does not teach the analgesic being selected from bupivacaine-meloxicam.
However, Gabriel et al. teaches a systemic, centrally, and peripherally acting analgesic selected from bupivacaine-meloxicam (“once HTX-011 is administered directly into the surgical wound, the polymer undergoes a steady hydrolysis that releases bupivacaine and meloxicam slowly over 3 days”, page 7, left col, paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Baeuerle with the use of bupivacaine-meloxicam of Gabriel et al. as an analgesic in order to provide lasting relief for chronic pain in patients, as well as address both physical and psychological components of chronic pain.
Regarding claim 14, Baeuerle in view of Gabriel et al. teaches the artificial sensory experience comprising virtual reality distraction therapy (“the artificial sensory experience is virtual reality as applied in virtual reality distraction therapy”, paragraph [0050]).
Regarding claim 15, Baeuerle in view of Gabriel et al. teaches receiving an artificial sensory experience comprising receiving virtual reality neuropsychological therapy (VRNT) wherein receiving the analgesic and receiving VRNT synergistically interact to reduce one or more of pain or analgesic usage (“artificial sensory experience, such as VRNT, with…physiological effects of analgesics can synergistically reinforce each other…can substantially increase the physiological and psychological efficacy of analgesics in reducing pain”, paragraph [0073]).
Regarding claim 16, Baeuerle in view of Gabriel et al. teaches the VRNT comprising a 4D sensory experience that is implemented as a 3D visual stimulus and at least one additional sensory stimulus selected from auditory, tactile, olfactory, and gustatory (“the VRNT comprises a 4D sensory experience…and gustatory”, claim 8).
Regarding claim 18, Baeuerle in view of Gabriel et al. teaches receiving an artificial sensory experience further comprises receiving a 3D sensory experience selected from: (i) a 3D visual stimulus or (ii) a 2D visual stimulus and at least one additional sensory stimulus selected from auditory, tactile, olfactory, and gustatory (“wherein receiving an artificial sensory experience…gustatory”, claim 20).
Regarding claim 19, Baeuerle in view of Gabriel et al. teaches the 3D sensory experience is received after receiving the VRNT and wherein the 3D sensory experience maintains the reduction of one or more of pain or analgesic usage (“when coupled with an artificial sensory experience (e.g., VRNT), the administered concentration of opioid analgesic rapidly decreases to a lesser concentration. The reduced concentration of opioid analgesic maintains the same level of (perceived or actual) pain”, paragraph [0086]).
Regarding claim 21, Baeuerle in view of Gabriel et al. teaches receiving an artificial sensory experience further comprising receiving a 2D visual sensory stimulus and wherein the 2D sensory experience maintains the reduction of one or more of pain or analgesic usage (“other artificial sensory experience…cumulative or lasting reduction of pain”, paragraph [0077]).
Regarding claim 23, a modified method of Baeuerle in view of Gabriel et al. teaches all the limitations of claim 22, but does not specifically teach wherein the 2D sensory experience is received after receiving the VRNT.
However, Baeuerle does teach wherein a 3D sensory experience could be received after VRNT (“wherein the 3D sensory experience is received after receiving the VRNT”, claim 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Baeuerle in view of Gabriel et al. and apply 2D sensory stimulus after the patient receives VRNT, and continue reduction of pain post-VRNT treatment.
Regarding claim 25, Baeuerle in view of Gabriel et al. teaches the artificial sensory experience generator (artificial sensory experience generator 104, Fig. 1) being configured to implement the virtual representation of the patient’s symptom (“generator can be configured…accurate virtual representation of one or more aspects of the patient’s symptom”, paragraph [0037]) based on user input received via an input device (“artificial sensory experience can be based on, for example, information received from the user via an input device”, paragraph [0038]; input device 110, Fig. 1), the user input being incorporated into a symptom visualization protocol which causes the output device to produce sensory stimuli representative of the symptom (“user input can be incorporated into one or more of a symptom visualization protocol…processed by processor…causes the output device to produce sensory stimuli representative of the symptom”, paragraph [0038]; symptom alleviation protocol 116, output device 112, Fig. 1)
Regarding claim 26, Baeuerle in view of Gabriel et al. teaches the artificial sensory experience (“artificial sensory experience is virtual reality”, paragraph [0055]) generator being configured to implement the virtual representation of the patient’s symptom by receiving a user drawing of the virtual representation of the symptom (“drawing and/or visualizing the pain to illustrate the pain…on an avatar representative of the patient”, paragraph [0055]) that is then displayed within the artificial sensory environment (“a head mounted display or other headgear (for visual feedback)”, paragraph [0055]).
Regarding claim 27, Baeuerle in view of Gabriel et al. teaches receiving the user drawing comprising receiving user selection of a symptom template (“virtual reality environment can…instruct the user to accomplish a task. The task may include…drawing and/or visualizing the pain…computer system and/or the user can then interact with the visualized pain and/or visualize its dampening”, paragraph [0055]).
Regarding claims 28 and 29, Baeuerle in view of Gabriel et al. teaches the artificial sensory experience generator generating the virtual representation of the symptom by providing a shape located on or within an avatar representing the user, wherein the shape is located on or within the avatar at a location associated with the real-world symptom of the user (“illustrate the pain as it would visually appear in location, color, intensity, and description (e.g., aching, pulsing, throbbing, stabbing, shooting, cramping, gnawing, burning, etc.) on an avatar representative of the patient”, paragraph [0055]). The “shape” is the area the user illustrates on the avatar, reflective of where they are feeling pain in the real-world.
Regarding claim 30, Baeuerle in view of Gabriel et al. teaches the artificial sensory experience generator additionally generating other sensory stimuli representative of the symptom, the other sensory stimuli comprising audio stimuli (“augmented reality can provide auditory…feedback…can help the user to…hear the pain in a way similar to how the user experiences the pain”, paragraph [0042]).
Regarding claim 31, Baeuerle in view of Gabriel et al. teaches the artificial sensory experience further comprising an alleviation protocol (“artificial sensory experience generators…can include…alleviation protocols”, paragraph [0061]; symptom alleviation protocol 116, Fig. 1) that implements a change to the virtual representation of the symptom representing an improvement in the symptom (“symptom visualizing protocols can be updated based on the received end- user data to more accurately reflect the user’s experience”).
Regarding claim 32, Baeuerle in view of Gabriel et al. teaches the alleviation protocol comprising modifying both visual and audio sensory stimuli associated with the symptom (“computer systems are configured to…execute…alleviation protocols, receive input from a user, and output various stimuli to the user”, paragraph [0056]). The alleviation protocols could modify various stimuli, such as visual and audio stimuli.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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, Alexander Valvis can be reached at 5712724233. 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.
/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791