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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 11-12, 14-25, 27-30, 35 and 37 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1, 11-12, 14-25, 27-30, 35 and 37 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.
Claim 1 recites “wherein the second location lies medial to a gripping surface of the user's hand and separated from the first location by least one inch, wherein the gripping surface of the user's hand does not include palmar or ventral surfaces of the user's gripping hand and includes the ventral/medial surfaces of the thumb, fingers, or other hand parts that would contact the hand-holdable housing”.
However page 4, lines 12-22 of the specification (paragraph 15 of US 20230211149 A1) recites “The second location 113 may lie medial to a grip surface of the user's hand. The term medial to a grip surface of the user's hand shall be understood to include any location on the surface of the user's body that does not include the palmar, or ventral, surfaces of the user's gripping hand, e.g., the palm and the ventral/medial surfaces of the thumb, or fingers or other hand parts that would contact the hand-holdable housing 114”.
As such, the specification does not provide support for “the gripping surface” to “include the ventral/medial surfaces of the thumb, or fingers or other hand parts” since the specification clearly recites “grip surface of the user's hand shall be understood to include any location on the surface of the user's body that does not include the palmar, or ventral, surfaces of the user's gripping hand, e.g., the palm and the ventral/medial surfaces of the thumb, or fingers or other hand parts”.
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 15-18, 20 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites “wherein the hand-holdable housing is shaped to cause the second electrode to contact the skin surface of the user's face at the second location when the first electrode is pressed against the skin surface of the user's face at the first location”. However, claim 1 from which claim 15 depends, recites “wherein the first and the second electrodes are arranged to contact the first and the second locations on the skin surface of the user's body… and wherein the second location lies medial to a gripping surface of the user's hand and …. the gripping surface of the user's hand … includes the ventral/medial surfaces of the thumb, fingers, or other hand parts that would contact the hand- holdable housing”. It is unclear how the second location can be located on the “skin surface of the user’s face” when “the second location lies medial to a gripping surface of the user's hand”.
Claim 20 recites “wherein the second electrode comprises a wrist strap that makes electrical contact with the user's wrist”. However, claim 1 from which claim 19 and 20 depend, recites “wherein the first and the second electrodes are arranged to contact the first and the second locations on the skin surface of the user's body… and wherein the second location lies medial to a gripping surface of the user's hand and …. the gripping surface of the user's hand … includes the ventral/medial surfaces of the thumb, fingers, or other hand parts that would contact the hand- holdable housing”. It is unclear how the second electrode at a second location can “makes electrical contact with the user's wrist” when “the second location lies medial to a gripping surface of the user's hand” and how “a wrist strap” is considered to be part of the “hand-holdable housing”.
Claim 22 recites “wherein the second electrode comprises a flexible member configured to drape over the user's shoulder”. However, claim 1 from which claim 19 and 22 depend, recites “wherein the first and the second electrodes are arranged to contact the first and the second locations on the skin surface of the user's body… and wherein the second location lies medial to a gripping surface of the user's hand and …. the gripping surface of the user's hand … includes the ventral/medial surfaces of the thumb, fingers, or other hand parts that would contact the hand- holdable housing”. It is unclear how the second electrode at a second location can “drape over the user’s shoulder” when “the second location lies medial to a gripping surface of the user's hand” where the “gripping surface of the user's hand and …. the gripping surface of the user's hand … includes the ventral/medial surfaces of the thumb, fingers, or other hand parts that would contact the hand- holdable housing”.
Additionally, it is unclear how the “hand-holdable housing” comprises a “flexible member to drape over the user’s shoulder”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 11-12, 14, 19, 21, 23-25, 27-30, 35 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Claude et al. (WO 2018/200443 A1).
As to claim 1, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses a handheld sinus treatment device (Abstract) with an electric current generation circuit (page 2, lines 9-14) having first (spring resilient member, depicted as 968 in Figures 9A-9C; page 32, lines 16-20) and second nodes (conductor between the return electrode and circuitry; Claude et al. disclose the return electrode is connected to the sinus treatment circuitry; Figures 4-5; “The current output circuit 429 includes the conductive tip 108 and the return electrode 110” page 17, lines 18-19; Therefore, in order to engage with the current output circuit, there is necessarily a node or conductor contact point that engages with the electrode), configured to output therapeutic electric current between the first and second nodes (Figure 10; page 2, lines 9-16); a first electrode (conductive tip, depicted as 108 in Figure 1A) operatively coupled to the first node (spring resilient member, depicted as 968 in Figures 9A-9C) of the electric current generation circuit, configured to couple electrical current between the first node of the electric current generation circuit and a first selected location on a skin surface of a user's body (page 32, lines 16-20); and a second electrode (return electrode, depicted as 110 in Figure 1A, 1C and 4) operatively coupled to the second node of the electric current generation circuit (page 17, lines 18-19; see above), configured to contact a second location on the skin surface of the user's body different than the first location and to form a current path between the second location and the second node of the electric current generation circuit (page 8, lines 25-31; page 13, lines 17-29), the second electrode having a larger contact area for contact with the second location than a contact area of the first electrode for contact with the first location (Figures 1A-1C); wherein the electric current generation circuit (sinus treatment circuitry; Figure 4) is disposed inside a hand-holdable housing (page 2, lines 21-23) and wherein the first electrode protrudes through the hand-holdable housing (Figures 1A-1C, 8 and 9A-9E); wherein the first and the second electrodes are arranged to contact the first and the second locations on the skin surface of the user's body selected to cause a current path to form along a targeted anatomical structure subcutaneous to the first location (Figure 1A-2; page 8, lines 25-31); and wherein the second location lies medial to a gripping surface of the user's hand (the second location, which engages with a portion of the hand, is located medial to the gripping surface (i.e., “the ventral/medial surfaces of the thumb, fingers, or other hand parts”) as seen in Figures 1A-1C) and separated from the first location by least one inch (Figures 1A-2; the examiner considers the second to be separated from the first location “by at least one inch” as depicted by the figures), wherein the gripping surface of the user's hand does not include palmar or ventral surfaces of the user's gripping hand and includes the ventral/medial surfaces of the thumb, fingers, or other hand parts that would contact the hand-holdable housing (page 5 , lines 10-13; page 8, lines 25-31).
As to claim 11, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses the first and second electrodes are spaced apart sufficiently to cause conduction of electrical current, from the first electrode through a targeted anatomical structure to be equal to or greater than conduction of electrical current along the skin surface of the user's body along the spaced apart distance (page 2, lines 9-27).
As to claim 12, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses the first and second electrodes are spaced apart a distance greater than a depth of the targeted anatomical structure below the skin surface of the human body (Figures 1-3B).
As to claim 14, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses the second electrode has a contact area greater than three times a contact area of the first electrode (Figures 1A-1C).
As to claim 19, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses a flexible coupling (overcoat; page 15, line 29 -page 16, line 1) between the hand-holdable case and the second electrode (since the overcoat covers a portion of the return electrode (i.e., the second electrodes), the examiner considers the overcoat to be “between the hand-holdable cases and the second electrode”).
As to claim 21, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses the second electrode is flexible (the return electrode includes an overcoat and thus since the return electrode size is modifiable, or flexible, the examiner considers the second electrode to be flexible; page 15, line 29 -page 16, line 1).
As to claim 23, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses the first location on the skin surface of the user's body comprises a location on the user's face (Figures 2-3B).
As to claim 24, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses the first location on the skin surface of the user's body comprises one of several treatment locations at or adjacent to the user's nose (Figures 2-3B).
As to claim 25, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses the first location on the skin surface of the user's body does not include a mucus membrane (Figures 2-3B).
As to claim 27, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses the first electrode includes a radiused conductor extending from the hand-holdable housing (Figure 8-9E).
As to claim 28, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses the first and the second electrodes are disposed coaxially (Figures 1A-1C).
As to claim 29, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses the first and the second electrodes are arranged side-by-side (Figures 1A-1C).
As to claim 35, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses the first and the second electrodes contact the first and the second locations on the skin surface of the user's body selected to cause a current path to form along a nerve fiber (Figure 2-3B).
As to claim 37, as best understood in light of the rejection under 35 U.S.C. 112, 1st paragraph above, Claude et al. discloses the first electrode is configured to couple electrical current to the first selected location without adhering to the first selected location (Figure 2); and wherein the second electrode is configured to contact the second location without adhering to the second location, without being held in contact by an adhesive (page 5 , lines 10-13; page 8, lines 25-31).
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 ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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, David E Hamaoui can be reached at (571) 270-5625. 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.
/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
Prosecution Insights