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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with all conditions for receiving the benefit of earlier filing dates of 18 May 2020, 05 Apr 2022, and 05 Sep 2023 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) for subject matter disclosed in provisional applications 63026177, 63327738, and 63536558, respectively.
Information Disclosure Statement
No information disclosure statement (IDS) has been filed in the instant case. Applicant is reminded of the requirements of 37 CFR 1.56. If applicant is aware of any materially relevant prior art, it should be submitted in an IDS for consideration. See MPEP 609 and 37 CFR 1.97 for further information.
Specification
The disclosure is objected to because of the following informality:
“[0088]” should be deleted in the Abstract.
Appropriate correction is required.
Claim Objections
Claims 1-2 and 12 are objected to because of the following informalities:
“the second bubbles on a left side of the patient’s heart” should read “the second bubbles on the left side of the patient’s heart” (claim 1);
“directing first bubbles” should read “directing the first bubbles” (claim 2); and
“first bubbles or second bubbles” should read “the first bubbles or the second bubbles” (claim 12).
Appropriate correction is required.
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 1-4, 6-10, and 12 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 the limitation “upon detecting the third bubbles on the left side of the patient's heart, initiating treatment to minimize risk of stroke in the patient”. A review of the specification, however, discloses surgically closing a shunt in the patient’s heart as the only treatment for when the third bubbles are detected on the left side of the patient’s heart (see at least [0049] of the specification of the instant application). Therefore, the claim is directed to a genus, when the specification discloses a species. Claims 2-4 and 6-8 inherit the deficiency by the nature of their dependency on claim 1.
Claim 4 recites the limitation “wherein initiating treatment comprises administering a blood thinner to the patient”. A review of the specification, however, discloses surgically closing a shunt in the patient’s heart as the only treatment for when the third bubbles are detected on the left side of the patient’s heart (see at least [0049] of the specification of the instant application). In fact, the specification discloses that the blood thinner is administered when the first bubbles are not detected in the left side of the patient’s heart (see at least [0049] of the specification of the instant application). Therefore, the claim 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, at the time the application was filed, had possession of the claimed invention.
Claim 9 recites the limitation “upon detecting the first bubbles on the left side of the patient's heart, intravenously directing second bubbles into the patient's venous circulatory system and to the right side of the patient's heart, the second bubbles having sizes that fall within a second range, the second range having sizes that are different than sizes in the first range”. A review of the specification, however, discloses the second bubbles having sizes larger, not just different, from the sizes of the first bubbles (see at least [0042]). The specification of the instant application does not disclose in sufficient detail that the second range of the second bubbles having sizes that are, for example, smaller than the sizes in the first range of the first bubbles. Claims 10-12 inherit the deficiency by the nature of their dependency on claim 9.
Claim 9 recites the limitation “upon detecting the second bubbles on the left side of the patient's heart, initiating treatment to minimize risk of stroke in the patient”. A review of the specification, however, discloses surgically closing a shunt in the patient’s heart as the only treatment for when the second bubbles that are larger than the first bubbles are detected on the left side of the patient’s heart (see at least [0049] of the specification of the instant application). Therefore, the claim is directed to a genus, when the specification discloses a species. Claims 10 and 12 inherit the deficiency by the nature of their dependency on claim 9.
Claim 10 recites the limitation “wherein initiating treatment comprises administering a blood thinner to the patient”. A review of the specification, however, discloses surgically closing a shunt in the patient’s heart as the only treatment for when the second bubbles that are larger than the first bubbles are detected on the left side of the patient’s heart (see at least [0049] of the specification of the instant application). In fact, the specification discloses that the blood thinner is administered when the first bubbles are not detected in the left side of the patient’s heart (see at least [0049] of the specification of the instant application). Therefore, the claim 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, at the time the application was filed, had possession of the claimed invention.
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 1-12 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 1 recites the limitations “monitoring the patient’s heart, with ultrasound imaging, to detect presence of the first bubbles on a left side of the patient’s heart; upon detecting the first bubbles on the left side of the patient’s heart, …”; “monitoring the patient’s heart, with ultrasound imaging, to detect presence of the second bubbles on a left side of the patient’s heart; and upon detecting the second bubbles on the left side of the patient’s heart, …”; and “upon detecting the third bubbles on the left side of the patient's heart, initiating treatment to minimize risk of stroke in the patient”. The metes and bounds of the claim is unclear in view of these contingent limitations. In particular, 1) detecting presence of at least first and second bubbles are recited to be an intended result of monitoring the patient’s heart; 2) it is unclear whether detecting the third bubbles is a required function of the claimed invention; and 3) it is unclear what happens when presence of any or all of the first, second, and third bubbles are not detected. See MPEP 2111.04.II. Claims 2-8 inherit the deficiency by the nature of their dependency on claim 1.
Claim 9 recites the limitations “monitoring the patient's heart, with ultrasound imaging, to detect presence of the first bubbles on a left side of the patient's heart; upon detecting the first bubbles on the left side of the patient's heart …” and “upon detecting the second bubbles on the left side of the patient's heart, initiating treatment to minimize risk of stroke in the patient …”. The metes and bounds of the claim is unclear in view of these contingent limitations. In particular, 1) detecting presence of the first bubbles is recited to be an intended result of monitoring the patient’s heart; 2) it is unclear whether detecting the second bubbles is a required function of the claimed invention; and 3) it is unclear what happens when presence of any of or both the first and second bubbles are not detected. See MPEP 2111.04.II. Claims 10-12 inherit the deficiency by the nature of their dependency on claim 9.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 5-11 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11986342 - hereinafter referred to as '342. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-3 and 5-11 of the instant application are anticipated by patented claims 1-7, respectively.
Patented claim 1 of ‘342 recites a method comprising: intravenously directing first bubbles into a patient's venous circulatory system and to a right side of the patient's heart, the first bubbles having sizes that fall within a first range; monitoring the patient's heart, with ultrasound imaging, and detecting presence of the first bubbles on a left side of the patient's heart; after detecting of the first bubbles on the left side of the patient's heart, intravenously directing second bubbles into the patient's venous circulatory system and to the right side of the patient's heart, the second bubbles having sizes that fall within a second range, the second range having sizes that are greater than sizes in the first range; monitoring the patient's heart, with ultrasound imaging, and detecting presence of the second bubbles on the left side of the patient's heart; after detecting of the second bubbles on the left side of the patient's heart, intravenously directing third bubbles into the patient's venous circulatory system and to the right side of the patient's heart, the third bubbles having sizes that fall within a third range, the third range having sizes that are greater than sizes in the second range; … and after detecting of the third bubbles on the left side of the patient's heart, surgically closing a shunt in the patient's heart using a catheter-delivered percutaneous closure device (“upon detecting the third bubbles on the left side of the patient’s hear, initiating treatment to minimize risk of stroke in the patient” in lines 19-20 of claim 1 of instant application). Therefore, the patented claim 1 of ‘342 is in essence a “species” of the generic invention of claim 1 of the instant application. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Patented claim 7 of ‘342 recites a method comprising: intravenously directing first bubbles into a patient's venous circulatory system and to a right side of the patient's heart, the first bubbles having sizes that fall within a first range; monitoring the patient's heart, with ultrasound imaging, and detecting presence of the first bubbles on a left side of the patient's heart; after detecting of the first bubbles on the left side of the patient's heart, intravenously directing second bubbles into the patient's venous circulatory system and to the right side of the patient's heart, the second bubbles having sizes that are greater than sizes in the first range (“the second bubbles having sizes that fall within a second range, the second range having sizes that are different than sizes in the first range” in lines 9-11 of claim 9 of instant application); … if the presence of the second bubbles is not detected on the left side of the patient's heart, then administering a prophylactic medication; and if the presence of the presence of the second bubbles is detected on the left side of the patient's heart, then surgically closing a shunt in the patient's heart. (“upon detecting the second bubbles on the left side of the patient’s hear, initiating treatment to minimize risk of stroke in the patient” in lines 12-13 of claim 9 of instant application). Therefore, the patented claim 7 of ‘342 is in essence a “species” of the generic invention of claim 9 of the instant application. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘342 in view of Eggers et al. (US Patent No. 11278261) – hereinafter referred to as Eggers.
Regarding claim 4, claim 1 of ‘342 discloses all limitations of claim 4 of instant application, but claim 1 of ‘342 does not disclose:
wherein initiating treatment comprises administering a blood thinner to the patient.
Eggers, however, discloses:
administering a blood thinner to a patient (Col 9, lines 32 -44: anticoagulant therapy to minimize possibility of cerebrovascular accidents and/or minimize the frequency of severity of migraines).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of claim 1 of ‘342 to include Eggers’s method of administering a blood thinner to a patient. The motivation for the combination would have been to “minimize the possibility of cerebrovascular accidents and/or minimize the frequency and severity of migraines”, as taught by Eggers (Col 9, lines 20-44).
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of ‘342 in view of Widder et al. (US Patent No. 5732707) – hereinafter referred to as Widder.
Regarding claim 12, claim 7 of ‘342 discloses all limitations of claim 12 of instant application, but claim 7 of ‘342 does not disclose:
determining blood flow rate, using ultrasound imaging, by monitoring movement of first bubbles or second bubbles within the patient’s heart.
Widder, however, discloses:
determining blood flow rate, using ultrasound imaging, by monitoring movement of bubbles within a patient’s heart (Col 2, lines 31-46 and claim 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of claim 7 of ‘342 to include Widder’s method of determining a blood flow rate. The motivation for the combination would have been to “assess valvular regurgitations, septal defects, cardiac output and other qualitative measurements of regional cardiac function”, as taught by Widder (Col 1, lines 65-67).
The following is the mapping between the claims of instant application under examination and the allowed claims of ‘342.
Claims of Instant Application
Claims of ‘342
1
1
2
2
3
3
4
1 + Eggers
5
1
6
4
7
5
8
6
9
7
10
7
11
7
12
7 + Widder
.
Allowable Subject Matter
Claims 1-12 would be allowable if rewritten or amended to overcome the 35 U.S.C. 112(a) and (b) rejections as well as a Terminal Disclaimer timely filed to overcome the Double Patenting rejections set forth above in this Office Action.
The following is a statement of reasons for the indication of allowable subject matter:
When the claims are considered as a whole, prior arts do not disclose, neither individually nor in combination, at least progressively administering bubbles of increasing sizes and detecting presence of these bubbles to determine the need to surgically close a shunt in the patient’s heart. Gurley et al. (US PG Pub No. 2011/0082373) discloses determining a shunt size based on a peak of microbubble detection in the left atrium (see at least [0059]); Moehring et al. (US PG Pub No. 2006/0264759) discloses determining a patent foramen ovale (PFO) based on a number of microbubbles detected in the left atrium (see at least Fig. 5); and Soliman et al. (Soliman et al. (2007). The use of contrast echocardiography for detection of cardiac shunts. Eur J Echocardiogrpahy, 8, S2-S12. doi: 10.1016/j.euje.2007.03.006. A copy attached to this Office action.) discloses counting number of bubbles seen in ultrasound image within three cardiac cycles for assessing a cardiac shunt size (see at least “Semi-quantification of shunt”). However, none of these discloses progressively administering bubbles of increasing sizes to determine a size of a cardiac shunt or hole. Additionally, Zhao et al. (Zhao et al. (2017). Comparison of Different Contrast Agents in Detecting Cardiac Right-to-Left Shunt in Patients with a Patent Foramen Ovale during Contrast-Transthoracic Echocardiography. BioMed Research International, Volume 2017, Article ID 6086094. doi: 10.1155/2017/6086094. A copy attached to this Office action.) discloses comparing different bubbles (inherently of two different sizes) between different subjects (see at least Abstract), but also does not disclose progressively administering bubbles of increasing sizes to determine a size of the PFO hole.
The technical advantage of the claimed invention is “to accurately assess the size of the shunt, in order to facilitate weighing of risks between repairing an ASD or PFO, or leaving it untreated surgically” ([0041] of the specification of the instant application). Specifically, bubbles of progressively increasing size are used to infer size of the shunt, thereby permitting different treatment decisions for the patient based on the size of the shunt detected and avoiding unnecessary surgeries.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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, Anhtuan Nguyen can be reached at 571-272-4963. 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.
/Y.C./Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
7/24/26
Prosecution Insights