Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Reissue Applications
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Continuing Obligations
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 10,639,468 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10-25-2024 has been entered.
Election/Restrictions
Claims 10-29 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.176 and MPEP § 1450, Non-Final Rejection of 11-03-2023 and Final Rejection of 07-01-2024.
Applicant failed to traverse the restriction requirement and therefore the election is FINAL.
Reissue Declaration of 10-25-2024
The reissue oath/declaration filed on 10-25-2024 is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following: the error which is relied upon to support the reissue application is not an error upon which a reissue can be based. See 37 CFR 1.175 and MPEP § 1414.
The reissue declaration has two first pages; one with inventor Ian Cook and the other with inventor Christopher DeGiorgio. The correct manner is to have a single first page with the first named inventor’s name and address and check the box that additional inventors are named on separately numbered sheets attached hereto; and then attach a supplemental numbered declaration sheet at the end with a location for the 2nd inventor’s name, date and address.
Furthermore, the error statement is incorrect in that while the claims filed on 10-25-2024 do include a broadened reissue claim, the broadened reissue claims are not claims 2, 3, 5 and 7 identified by Applicant, but rather claim 1. See MPEP 1412.03 below:
1412.03 Broadening Reissue Claims [R-10.2019]
35 U.S.C. 251 Reissue of defective patents
*****
(d) REISSUE PATENT ENLARGING SCOPE OF CLAIMS.—No reissued patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the original patent.
35 U.S.C. 251(d) and the corresponding final paragraph of pre-AIA 35 U.S.C. 251 prescribe a 2-year limit for filing applications for broadening reissues.
I. MEANING OF "BROADENED REISSUE CLAIM"
A broadened reissue claim is a claim which enlarges the scope of the claims of the patent, i.e., a claim which is greater in scope than each and every claim of the original patent.
A claim of a reissue application enlarges the scope of the claims of the patent if it is broader in at least one respect, even though it may be narrower in other respects. See, e.g., 37 CFR 1.175(b). A claim in the reissue application which includes subject matter not covered by the patent claims enlarges the scope of the patent claims. For example, if any amended or newly added claim in the reissue contains within its scope any conceivable product or process which would not have infringed the patent, then that reissue claim would be broader than the patent claims. Tillotson, Ltd. v. Walbro Corp., 831 F.2d 1033, 1037 n.2, 4 USPQ2d 1450, 1453 n.2 (Fed. Cir. 1987); In re Ruth, 278 F.2d 729, 730, 126 USPQ 155, 156 (CCPA 1960); In re Rogoff, 261 F.2d 601, 603, 120 USPQ 185, 186 (CCPA 1958). A claim which covers something that the original claims do not is a broadened claim. A claim would be considered a broadening claim if the patent owner would be able to sue any party for infringement who previously could not have been sued for infringement. Thus, where the original patent claims only the process, and the reissue application newly adds product claims, the scope of the claims has been broadened because a party could not necessarily be sued for infringement of the product based on the claims of the original patent (if it were made by a different process).
II. SCOPE OF DEPENDENT CLAIM ENLARGED - NOT BROADENING
As pointed out above, a claim will be considered a broadened reissue claim when it is greater in scope than each and every claim of the patent to be reissued. A corollary of this is that a claim which has been broadened in a reissue as compared to its scope in the patent is not a broadened reissue claim if it is narrower than, or equal in scope to, any other claim which appears in the patent. A common example of this is where dependent claim 2 is broadened via the reissue (other than the addition of a process step to convert an intermediate to a final product), but independent claim 1 on which it is based is not broadened. Because a dependent claim is construed to contain all the limitations of the claim upon which it depends, claim 2 must be at least as narrow as claim 1 and is thus not a broadened reissue claim.
Since dependent claims 2, 3 and 5-7 are narrower than original patent claim 1 they are not broader than every claim of the patent. However, the manner in which Applicant has amended claim 1 makes it broader than each and every claim of the patent. This is because original patent claim 1 has a limitation that the medical disorder to be treated was ADD and/or ADHD. Claim 1 has been amended such that the preamble now is a method for treating a medical disorder associated with ADD and/or ADHD. Many other disorders besides ADD or ADHD are merely “associated” with ADD and/or ADHD. The declaration error statement must include this error by identifying claim 1, cite the language that is broader in scope than that of the original patent claim 1, and then explain how the language of original patent claim 1 made the original patent at least partially inoperative or invalid. A couple examples which would satisfy the “how” requirement are that the original language of claim 1 was unduly narrow or unnecessary for patentability.
Claims 1-9 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office action.
Claim Rejections - 35 USC § 251 - Original Patent
The following is a quotation of the first paragraph of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
MPEP 1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP 1412.01 further provides guidelines for determining whether the reissue claims are "for the invention disclosed in the original patent" as:
(A) the claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 U.S.C. 112, first paragraph is satisfied; and
(B) nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application, and
(C) the newly claimed invention is clearly and unequivocally disclosed in the specification as a separate invention with the claimed combination of features.
The presence of some disclosure (description and enablement) in the original patent should evidence that applicant intended to claim or that applicant considered the material now claimed to be his or her invention.
Further, the Federal Circuit addressed the “original patent” requirement of 35 USC 251 in Antares Pharma, Inc. v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014). In Antares the reissue claims covered embodiments of injection devices (not restricted to jet-injection devices) which the Applicant admitted was a different invention from what was originally claimed. Id. at 1356. The Federal Circuit adopted the Supreme Court's explanation of the “same invention” requirement as “if the original patent specification fully describes the claimed inventions, but not if the broader claims are merely suggested or indicated in the original specification”. Id. at 1359. The Federal Circuit further stated that although wording in 35 USC 251 was changed from “same invention” to “original patent” no change in substance was intended. Id. at 1360.
Based on Antares a review of the specification is necessary to determine whether the original specification adequately discloses the invention of the reissue claims. Like in Antares, in the instant reissue application the disclosure does not support the limitations of:
“A method for treating a medical disorder associated with attention deficit disorder (ADD) and/or attention deficit hyperactivity disorder (ADHD)” and
“inhibiting a superior parietal cortex and a temporal-occipital cortex [to treat a medical disorder, the medical disorder selected from the group consisting of attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD)]” in claim 1.
This is new matter unsupported by the original disclosure as it is unclear and was not disclosed exactly what disorders meet this limitation due to the term “associated”. This is exacerbated by the specific electric signals claimed in many dependent claims as no disclosure exists for specific electric signals treating specific disorders “associated” with ADD and/or ADHD. It is also new matter and unsupported by the original disclosure in that the removal of claim text significantly broadens the claim in that the treatment is no longer limited to treating ADD and/or ADHD but includes disorders “associated” with ADD and/or ADHD.
As the original specification fails to clearly and unequivocally disclose the newly claimed inventions as separate inventions, claims 1-9 do not satisfy the “original patent” requirement.
Claims 1-9 are therefore rejected under 35 USC 251 for not claiming subject matter directed to the invention disclosed in the original patent.
Reissue New Matter
Claims 1-9 are rejected under 35 U.S.C. 251 as being based upon new matter added to the patent for which reissue is sought.
The following amendments to the specification and claims contain new matter:
In the amendment to the claims of 10-25-2024, “A method for treating a medical disorder associated with attention deficit disorder (ADD) and/or attention deficit hyperactivity disorder (ADHD)” and
“inhibiting a superior parietal cortex and a temporal-occipital cortex [to treat a medical disorder, the medical disorder selected from the group consisting of attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD)]” in claim 1 is new matter and is unsupported by the original patent disclosure as it is unclear and was not disclosed exactly what disorders meet this limitation due to the term “associated”. This is exacerbated by the specific electric signals claimed in many dependent claims as no disclosure exists for specific electric signals treating specific disorders “associated” with ADD or ADHD. It is also new matter unsupported by the original patent disclosure in that the removal of claim text significantly broadens the claim in that the treatment is no longer limited to treating ADD or ADHD but includes disorders “associated” with those two disorders. New matter is not limited to the addition of undisclosed text or information but can also be the removal of such.
608.04(a) Matter Not Present in Specification, Claims, or Drawings on the Application Filing Date [R-10.2019]
Matter not present on the filing date of the application in the specification, claims, or drawings that is added after the application filing is usually new matter. See MPEP §§ 2163.06 and 2163.07 for guidance in determining whether an amendment adds new matter, and for a discussion of the relationship of new matter to 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See MPEP § 2163.07(a) to determine whether added characteristics such as chemical or physical properties, a new structural formula or a new use are inherent characteristics that do not introduce new matter.
New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.
2163 Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, "Written Description" Requirement [R-01.2024]
B. New or Amended Claims
Under certain circumstances, omission of a limitation can raise an issue regarding whether the inventor had possession of a broader, more generic invention. See, e.g., PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1248, 64 USPQ2d 1344, 1353 (Fed. Cir. 2002) (Claim for a method of inhibiting sprout growth on tubers by treating them with spaced, sequential application of two chemicals was held invalid for lack of adequate written description where the specification indicated that invention was a method of applying a "composition" containing the two chemicals.); Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir. 1998) (claims to a sectional sofa comprising, inter alia, a console and a control means were held invalid for failing to satisfy the written description requirement where the claims were broadened by removing the location of the control means); Johnson Worldwide Assoc. v. Zebco Corp., 175 F.3d 985, 993, 50 USPQ2d 1607, 1613 (Fed. Cir. 1999) (stating that, in Gentry Gallery, the "court’s determination that the patent disclosure did not support a broad meaning for the disputed claim terms was premised on clear statements in the written description that described the location of a claim element--the ‘control means’ --as ‘the only possible location’ and that variations were ‘outside the stated purpose of the invention.’ … Gentry Gallery, then, considers the situation where the patent’s disclosure makes crystal clear that a particular (i.e., narrow) understanding of a claim term is an ‘essential element of [the inventor’s] invention.’"); see also Tronzo v. Biomet, 156 F.3d at 1158-59, 47 USPQ2d at 1833 (Fed. Cir. 1998) (claims to generic cup shape were not entitled to filing date of parent application which disclosed "conical cup" in view of the disclosure of the parent application stating the advantages and importance of the conical shape.). A claim that omits an element that applicant describes as an essential or critical feature of the invention originally disclosed does not comply with the written description requirement. See Gentry Gallery, 134 F.3d at 1480, 45 USPQ2d at 1503; In re Sus, 306 F.2d 494, 504, 134 USPQ 301, 309 (CCPA 1962) ("[O]ne skilled in this art would not be taught by the written description of the invention in the specification that any ‘aryl or substituted aryl radical’ would be suitable for the purposes of the invention but rather that only certain aryl radicals and certain specifically substituted aryl radicals [i.e., aryl azides] would be suitable for such purposes."(emphasis in original)). A claim which omits matter disclosed to be essential to the invention as described in the specification or in other statements of record may also be subject to rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as not enabling, or under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); In re Venezia, 530 F.2d 956, 189 USPQ 149 (CCPA 1976); and In re Collier, 397 F.2d 1003, 158 USPQ 266 (CCPA 1968). See also MPEP § 2172.01.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
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 1-9 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 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.
The specification fails to provide an adequate written description of the invention as now claimed.
Regarding claim 1, the specification fails to provide any specifics with respect to treatment of disorders which would be considered “associated with ADD and/or ADHD”. The specific electrical signals found in many of the dependent claims are specifically tailored to treating ADD and/or ADHD and therefore there is no support for any associated disorders, especially with respect to the use of the specific electrical signals found in the dependent claims. While the same signal parameters are disclosed as treating other disorders it is certainly not clear out of these which ones would be considered “associated” with ADD and/or ADHD.
It is also new matter in that the removal of claim text significantly broadens the claim in that the treatment is no longer limited to treating ADD or ADHD but includes disorders “associated” with those two disorders. New matter is not limited to the addition of undisclosed text or information but can also be the removal of such.
Regarding claim 4, the “greater than 10 mA/cm2” is again missing “approximately” which is how this output current density (OCD) is disclosed in the specification. Therefore the claimed OCD is not supported by the original disclosure.
The original specification fails to provide sufficient evidence that a POSITA would have known that the inventor had possession of the newly claimed invention at the time the application was filed.
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 1-9 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.
The examiner contends that the preamble of claims 1-9 is limiting. As indicated below in MPEP 2111.02 if the preamble is necessary to give life, meaning and vitality to the claim then it is within the scope of the claim. As best can be understood at this time the examiner contends that the BRI of claim 1 includes that the recited steps are performed to treat ADD and/or ADHD. This would of course require that the patient on which the steps are performed has or exhibits ADD and/or ADHD.
If this is not Applicant’s intent then amendments and arguments must be presented to rebut this finding. Ultimately it is unclear what Applicant intends the phrase “for treating a medical disorder associated with attention deficit disorder (ADD) and/or attention deficit hyperactivity disorder (ADHD)” in the preamble means given Applicant’s own stated position regarding this point. On page 14 of the response of 04-30-2024 Applicant states: Claim 1 has been amended to clarify that the claim is directed to treating a medical disorder, and that treating a medical disorder is not intended to be a positively recited step as this has been moved to the claim preamble. Claim 1’s preamble has been further amended but it is unclear if the above is still Applicant’s position in that Applicant contends that the actual treating of the disorder is not a positively recited step of the claimed method. If treating is not a positively recited step of the claimed method then the method claim is incomplete and the scope of the claim is not determinable. A method for treating by definition must include treatment. Applicant’s position begs the question if prior art disclosed the contacting and applying steps as claimed, but did those steps for some other purpose or for treating some other ailment or disorder, would this prior art disclosure anticipate claim 1? Another question would be if the contacting and applying steps are performed on a patient who does not have any disorders what exactly is the result of this method being performed? What exactly has been accomplished? Has any treatment been provided or administered?
As best can be understood at this time the examiner contends that the BRI of the claim includes performing the recited steps in the treatment of ADD and/or ADHD. This would require that the patient has or exhibits ADD and/or ADHD.
Response to Arguments
The request for suspension of the present reissue has again been denied. As there are correctable errors in the present reissue and the original patent claims have been amended and are not allowable, the present reissue will not be suspended. See MPEP 1450 II. The rejection based on a deficient reissue declaration will not be held in abeyance.
As explained above the amendments to claims 2, 3, and 5-7 are not broadening amendments in this reissue for the reasons provided above. A new reissue declaration is required.
Conclusion
Claims 1-9 are rejected.
Claims 10-29 have been withdrawn.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eileen Lillis who can be reached at 571-272-6928.
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, please visit: https://patentcenter.uspto.gov. For more information about Patent Center, please visit https://www.uspto.gov/patents/apply/patent-center, and for information about filing in DOCX format, please visit https://www.uspto.gov/patents/docx. 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.
Any inquiry concerning this communication or earlier communications from the Reexamination Legal Advisor or Examiner, or as to the status of this proceeding, should be directed to the Central Reexamination Unit at telephone number (571) 272-7705.
Signed: /GLENN K DAWSON/
Primary Examiner, Art Unit 3993
Conferees: /WILLIAM E DONDERO/ Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/SPRS, Art Unit 3993