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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/26/2026 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on 05/26/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 10,960,060 has been reviewed and was accepted on 05/29/2026. The terminal disclaimer has been recorded.
Priority
As discussed in the previous office action, applicant has erroneously claimed foreign priority to U.S. non-provisional application 16/875,945 (filed on 05/15/2020) in the Application Data Sheet dated 11/15/2022. In their response, Applicant has indicated that they have submitted a new Application Data Sheet. The office has not received the updated application data sheet. Accordingly, applicant is advised that the instant application still requires an updated Application Data Sheet in order to correct the priority claim.
In the interest of compact prosecution, applicant is directed to Patent Center to file a corrected ADS or applicant may contact the Application Assistance Unit for assistance in correcting the priority claim.
Amendments
Claims 1, 8, 10, and 20 have had minor typographic changes.
Claims 2-6 now introduce the list of nerves by stating that they “[are] selected from the group consisting of”.
Claim 11 has been amended to define CGRP.
Claim Objections
Previous objections to the claims
Claims 5 and 11 were previously objected to for minor informalities. Applicant has addressed these deficiencies. Therefore, the objections have been withdrawn.
Claim Interpretation
Claims 1-20 are directed to “treatment” of arrhythmia. Applicant defines the term “treating” to mean “delaying, alleviating, mitigating, or reducing the intensity, progression, or worsening of one or more attendant symptoms of a disorder or condition and/or alleviating, mitigating or impeding one or more causes of a disorder or condition” and “[t]reatment under the claimed invention may be a preventative treatment, prophylactic treatment, remission of treating or ameliorating treatment” (Specification, p. 7, par. 3). Accordingly, the claims have been interpreted to be directed to the preventative treatment, prophylactic treatment, remission treatment, or ameliorating treatment.
Claims 9 and 14 recite the approximation “about”. Applicant defines the term “about” in the context of a numerical value or range to mean ± 10% of the numerical value or range recited or claimed (Specification, p. 7, par. 2). Accordingly, this definition has been applied to claims 9 and 14.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
(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.
Previous rejections under 35 U.S.C. § 112(a)
RE: Rejection of claims 1-20 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement.
Applicant traverses the rejection of record by arguing the following.
First, applicant argues that the final office action improperly reads “preventative treatment” into the claim of “treating arrhythmia in a patient in need thereof”. Specifically, applicant asserts that a person of skill in the art would understand that the phrase “patient in need thereof” must be read with “treating arrhythmia” which requires a patient who has or whose condition calls for treatment of arrhythmia. Applicant argues that when viewed in the context of the whole application, the statement that the treatment “may be a preventative treatment, prophylactic treatment, remission of treating or ameliorating treatment” does not expand “treatment” to the prophylactic setting and at most confirms “that treatment can include preventing or impeding recurrence, progression, or worsening in a patient whose condition calls for treatment” (Remarks, p. 6, par. 4). Applicant supports this argument by citing the working example wherein a patient who suffered from cardiac arrhythmia received botulinum toxin injections and because this disclosure concerns treatment of a patient with arrhythmia and recurrence of symptoms, the phrase “treatment” does not extend to unwarranted administration to a patient who has not been diagnosed with arrhythmia. Accordingly, applicant argues that “treating” must be read with a patient “in need thereof” and the claims are therefore enabled.
Second, applicant argues that the use of any amount of toxin within the range of 1-4 units per site is enabled by the disclosure’s teaching of 2 units because a person of skill in the art would consider the teachings of the whole application when choosing a dosage and would also make dose adjustments based on age and weight and would understand that the therapeutically effective amount can be as low as 1 unit.
Third, applicant argues that the scope of the claims which encompasses any botulinum toxin is not overly broad when viewed in context of the disclosure. Specifically, applicant argues that the specification identifies the mechanisms of action of botulinum toxins A, B, C, D, E, F, and G and the specification also acknowledges that potency, dosage, or duration may vary depending on the toxin type and the selection of available botulinum toxin preparations is well within ordinary skill and routine medical practice.
Fourth, applicant argues that the claims are not encompassing of a single-site regimen despite the use of “and/or” language because the specification provides a working example with a specific multi-site regimen and “a person of skill in the art would understand that the claimed method encompasses multi-site injections of botulinum toxin and is enabled by the specification” (Remarks, p. 9, par. 2).
Fifth, applicant argues that routine monitoring of biomarkers and symptoms is standard clinical practice and is not the type of trial-and-error experimentation that constitutes undue experimentation under Wands. Specifically, applicant argues that the specification teaches monitoring of neuroexcitatory substances including blood glutamate and timing for monitoring. Moreover, applicant asserts that the dependent claims provide additional guidance for practitioners and reflects ordinary clinical tailoring not undue experimentation.
Each of applicant’s above arguments have been fully considered but are not sufficient to overcome the rejection of record for the reasons discussed below.
With respect to the first argument (breadth of “treatment”), under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification (MPEP § 2173.01(I)). In this case, although “treatment” may ordinarily be considered to encompass the therapeutic alleviation of a condition, the special definition provided by applicant is:
“delaying, alleviating, mitigating, or reducing the intensity, progression or worsening of one or more attendant symptoms of a disorder or condition and/or alleviating, mitigating or impeding one or more causes of a disorder or condition” and “Treatment under the claimed invention may be a preventative treatment, prophylactic treatment, remission of treating or ameliorating treatment” (Specification, p. 7, par. 3).
The examiner agrees with applicant that “treatment” must be read with “patient in need thereof” but that does not necessarily preclude all prophylactic treatments. For example, the examiner agrees that a “patient in need” of prophylactic treatment of arrhythmia must be a patient “who has, or whose condition calls for treatment of, arrhythmia” (Remarks, p. 6, par. 3) because that is the plain meaning of “in need thereof” when used in conjunction with “treatment”. Thus, the claims encompass prophylactic or preventative treatment of any patient who has been deemed to be “in need of” such therapy. For this reason, the claim still encompasses the prophylactic aspect of treating arrhythmia and the specification does not provide any evidence that administration of botulinum toxin in the prophylactic setting (i.e., to a patient whose conditions calls for prophylactic treatment of arrhythmia) can actually delay, alleviate, mitigate, or reduce the intensity, progression or worsening of arrhythmia. As argued throughout prosecution, there is no clear expectation that a patient could be administered any serotype of botulinum toxin to one or more of the recited nerve groups in an amount of 1-4 units and be expected to prevent the development of an arrhythmia. This aspect must be read into the claims because the specification clearly states that “preventative” and “prophylactic” treatment are encompassed by the scope of “treating” and the claims must be read in light of the special definition.
With respect to the second argument (dosage ranges), although the Examiner agrees that a person having ordinary skill in the art could routinely experiment with different dosages, the consideration of Wands must be made in conjunction with the evidence as a whole. As discussed in the rejection of record, the differences between the scope of the claimed invention and what is actually shown in the specification is considerable. The instant claims encompass the administration of as few as 1 unit of any botulinum toxin to a patient in order to achieve a broad range of “treatments”. When looking to applicant’s disclosure, a person having ordinary skill in the art would be confronted with a single working example wherein a patient was allegedly “treated” (amelioration treatment) with a total of 52 units of botulinum toxin (Specification, p. 19, par. 3)(although it is noted that the subject had a recurrence of symptoms requiring additional botulinum administration). This, especially when viewed in the context of Avery (which teaches that the answer to whether botulinum toxin can quell atrial fibrillation is “maybe”; p. 2, par. 2), does not reasonably enable the invention. For the reasons discussed above, there is at least some uncertainty in the art as to whether botulinum toxin can treat arrhythmia. Thus, the question is not whether a person having ordinary skill in the art could routinely experiment with another dose (they could); instead, the question is whether a person having ordinary skill in the art could routinely experiment with another dose in order to arrive at “treatment of arrythmia” without undue experimentation (they could not). Given the evidence of record, the uncertainty in the art, what is actually shown in applicant’s disclosure, the breadth of the claims, and what actually constitutes experimentation (e.g., regulated trials involving injection of potent toxins into the nerves of subjects), the amount of experimentation is clearly undue.
With respect to the third argument (the type of botulinum toxin), although the examiner agrees that a person having ordinary skill in the art could select a botulinum toxin through routine experimentation, as discussed above in the response to the second argument, the question is whether a person having ordinary skill in the art could select any botulinum toxin and arrive at a method of treating arrhythmia using as few as 1 unit of said toxin without undue experimentation. Applicant’s working examples involve the use of 52 units of an undisclosed type of botulinum toxin. Thus, when viewed in the context of the rest of the Wands factors and the evidence as a whole, there is clearly undue experimentation needed to arrive at a method of “treating” arrhythmia commensurate with the scope of the term “treatment” when using any type of botulinum toxin.
With respect to the fourth argument (the multi-site nature), the Examiner disagrees with applicant’s position that the scope of the claims does not include administration to as little as one site. Applicant asserts that a person having ordinary skill would understand that the claimed methods are preferably applied to all or many of the described locations and based on the working example and said person would understand that “the claimed method encompasses multi-site injections of botulinum toxin” (Remarks, p. 9, par. 2). Although the claims clearly encompass multi-site injection, that does not mean that they exclude single site injection because such an interpretation would be clearly contradictory to the plain language of the claim. Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims (MPEP § 2173.05(q)). In this case, it is unreasonable and improper to read multi-site injection into the claims merely because the working example (and discussion of the preferable limitations) involves multi-site administration. The clear language of the claims is that administering botulinum toxin comprises administering 1-4 units to as few as one dermatome (by virtue of the “and/or” language in line 7 of claim 1). Thus, the claim must be read to encompass single-site administration. As discussed in the rejection of record, applicant’s disclosure clearly contradicts the enablement of such a regimen by teaching a need to inject “not only to the directly involved dermatomes but also the rest of the sensory dermatomes because if these areas are overproducing the excitatory neural peptides, they can diffuse up and down the spinal cord and produce overstimulation of other nerves by a process called central stimulation” (Specification, p. 22, par. 2). Thus, there is clearly a low expectation of success and conversely a high level of experimentation needed to enable single-site administration (not to mention any multi-site administration of any subset of the nerves recited in this claim).
With respect to the fifth argument (monitoring or follow-on steps), the Examiner agrees that performing a process such as monitoring blood glutamate is not an undue experimentation. The rejection of record does not assert that this is what is undue. Rather, the consideration of enablement is made upon consideration of the Wands factors and the evidence as a whole. The follow-on steps are merely one component which demonstrate that the claims are not necessarily enabled absent undue experimentation. As discussed throughout prosecution, the claims are so broad in that they contemplate (and, in the case of some dependent claims, encompass) complete abandonment of the claimed botulinum toxin therapy if the patient’s neuroexcitatory substances level fails to normalize by instead achieving “treatment” through administration of an antagonist to the neuroexcitatory substances (see, e.g., claims 17 and 20). Thus, the disclosure clearly sets forth that the administration of botulinum toxin does not always “treat” arrhythmia (by virtue of the step of “monitoring if the patients neuroexcitatory substance level normalizes”; i.e., checking if the method worked). This position is supported by applicant’s disclosure which states “[t]he claimed invention proposes to treat some if not all of the 30% of cardiac arrhythmias not caused by direct problems to the heart” (Specification, p. 22, par. 3; emphasis added). Thus, a person having ordinary skill in the art would be required to perform all of the experimentation in order to actually use the invention because for every patient said person would have to (1) administer 1-4 units of any botulinum toxin to any, some, or all of the dermatomes identified in the claims, (2) monitor the patient to see if the method actually worked, and then (3) either (a) change the method, reapply the modified method, and re-monitor, (b) administer an additional botulinum toxin, or (c) abandon the method entirely and administer an antagonist to the neuroexcitatory substances. This level of experimentation is clearly undue especially when view in the context of the prior art which raises uncertainty about the ability of botulinum toxin to achieve such an effect.
In conclusion, the question of enablement does not turn on one single factor but instead turns on the consideration of each of the Wands factors and the evidence as a whole. As discussed in the rejection of record, because none of the prior art teaches applicant’s claimed invention, a person having ordinary skill could look only to applicant’s disclosure to enable the claimed invention. Even in the narrowest embodiment (i.e., using the regimen described in Example 1), the method does not appear to achieve “treatment” (within the special definition of the term) because after 52 units of botulinum toxin were administered to the patient, said patient still had arrhythmia (“the patient felt a few rapid heart rates occasionally”; Specification, p. 22, par. 2) and required additional dosing of 16 units (Id.). Thus, it is unclear if treatment was achieved and even if treatment was achieved, there is clearly an undue amount of experimentation needed to enable “treatment” within the context of the actual method claims.
For at least these reasons, the rejection of record is proper and has been maintained.
Maintained rejection under 35 U.S.C. § 112(a)
Claims 1-20 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement.
The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors considered when determining if there is sufficient evidence to support that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). MPEP § 2164.04
further states that although the analysis and conclusion of a lack of enablement are based on these factors and the evidence as a whole, it is not necessary to discuss each factor in the enablement rejection.
With respect to the nature of the invention and the breadth of the claims, applicant’s invention is directed to methods for treating arrhythmia in a patient in need thereof. The generic method (claim 1) requires the active step of “administering botulinum toxin to the patient, thereby treating arrhythmia”. Claim 1 then limits the dosage and location of injection and recites a step of “monitoring if the patient’s neuroexcitatory substances level normalizes”. The botulinum toxin is not particularly limited and encompasses any botulinum toxin (see, e.g., claim 7 for examples of botulinum toxins).
Claims 2-8 limit the administration regimen.
Claims 9-10 limit the total dosage of the botulinum toxin.
Claim 11 limits the neuroexcitatory substance to comprise substance P, CGRP, or glutamate.
Claim 12 limits the patient’s neuroexcitatory substances to be “blood level”.
Claims 13-14 limit the “monitoring” step to comprise “monitoring if the patient’s blood glutamate level normalizes”.
Claims 15-16 further require a step of administering an additional botulinum toxin if the patient’s neuroexcitatory substances level fails to normalize.
Claim 17 further requires a step of administering an antagonist of the neuroexcitatory substance if the patient’s neuroexcitatory substances level fails to normalize.
Claim 18 limits the “monitoring” step to occur one or two weeks after the administering step.
Claim 19 further requires monitoring the patient’s arrhythmia symptoms.
Claim 20 further requires a step of administering additional botulinum toxin or an antagonist to the neuroexcitatory substances if the patient’s arrhythmia symptom continues.
As discussed above, applicant defines the term “treating” to mean “delaying, alleviating, mitigating, or reducing the intensity, progression, or worsening of one or more attendant symptoms of a disorder or condition and/or alleviating, mitigating or impeding one or more causes of a disorder or condition” and “[t]reatment under the claimed invention may be a preventative treatment, prophylactic treatment, remission of treating or ameliorating treatment” (Specification, p. 7, par. 3). Thus, the breadth of the claims encompasses preventative, prophylactic, remission, or amelioration treatment including delaying, alleviating, mitigating, or reducing the intensity, progression or worsening of one or more symptoms of arrhythmia.
With respect to the state of the prior art, Abiad et al. (US 2018/0071361 A1; cited in the 14 page IDS dated 10/12/2023) teaches that arrhythmias are caused by a disruption of the normal functioning of the electrical conduction system of the heart ([0205]) and teaches a method for treating cardiac arrhythmia comprising the step of administering a composition comprising a therapeutically effective amount of Clostridial toxin administered locally to the heart of a patient with a cardiac arrythmia or at risk of a cardiac arrythmia ([0207]). Abiad’s methods are limited to the intracardiac administration of Clostridial toxin with no teaching or suggestion of the administration to the recited nerves. Pokushalov et al. (Circulation: Arrhythmia and Electrophysiology, 2015, Vol. 8, Issue 6, pages 1334-1341) teaches that injection into the epicardial fat pads of patients reduced cardiac autonomic nervous system activity and provided substantial postoperative atrial fibrillation suppression after coronary artery bypass graft (CABG) without any serious adverse events (p. 1340, left col., par. 5). Figure 3 (p. 1338) demonstrates that although atrial fibrillation burden may decrease spontaneously (as seen in the placebo group), the botulinum toxin group exhibited reduction in atrial fibrillation. Avery (Duke Health, Webpage, Published November 15, 2017, https://corporate.dukehealth.org/news/botulinum-toxin-atrial-fibrillation-maybe-more-study-needed, Accessed: April 2025) teaches that Duke University researchers reported at a public American Heart Association Meeting that the answer to whether botulinum toxin can quell atrial fibrillation is “maybe” (p. 2, par. 2). Specifically, the Duke University researchers launched their inquiry due to Pokushalov’s disclosure and concluded that “the results from [Pokushalov] were very interesting, but needed to be replicated on a larger and more medically complex group of patients” and Duke’s researchers expanded on this study and found that although the botulinum toxin-receiving group had shorter initial bouts of atrial fibrillation, there was no significant difference in length of hospital stay or post-operative complications, including risk of atrial fibrillation (p. 2, par. 4 through p. 3, par. 1).
Neither the above references nor the art as a whole teach or suggest “treatment” (within the context of applicant’s special definition) of arrythmias by administering botulinum toxin to the nerves of a patient.
With respect to the amount of direction provided by the inventors and the existence of working examples, applicant provides one working example wherein a single patient suffering from cardiac arrhythmia was injected with 2 units of botulinum toxin to and/or around the vicinity of an ophthalmic, maxillary, and/or mandibular nerve of the trigeminal nerve bilaterally, lateral to the patient's spine, 2 units to and/or around the vicinity of the c-2 to c-3, c-4 to c-6, and/or c-7 to c-8 of the cervical nerve bilaterally, lateral to the patient's spine, 2 units to and/or around the vicinity of the t-2 to t-3, t-5 to t-6, t-7 to t-9, and/or t-10 to t-12 of the thoracic nerve bilaterally, lateral to the patient's spine, 2 unit to and/or around the vicinity of the 1-1 to 1-2, 1-2 to 1-3, and/or 1-4 to 1-5 of the lumbar nerve bilaterally, lateral to the patient's spine, and/or 2 units to and/or around the vicinity of the s-1 to s-2, s-3 to s-4, and/or s-4 to s-5 of the sacral nerve bilaterally, lateral to the patient's spine, total of 52 units (Specification, p. 19, par. 3). After two weeks, the patient reported a resolution of the arrhythmia which was confirmed by arrhythmia monitoring (Specification, p. 20, par. 1). Applicant has not disclosed which “botulinum toxin” was used in the working example.
Additionally, applicant teaches that “[i]t will be necessary to give the botulinum toxin not only to the directly involved dermatomes but also the rest of the sensory dermatomes because if these areas are overproducing the excitatory neural peptides, they can diffuse up and down the spinal cord and produce overstimulation of other nerves by a process called central stimulation” (Specification, p. 22, par. 2).
With respect to the level of one of ordinary skill, a person having ordinary skill in the art is a person having an advanced understanding of medical or biological sciences.
With respect to the level of predictability and the quantity of experimentation, as discussed above, there is no example in the prior art which teaches the “treatment” (within the scope of applicant’s definition) of arrhythmia in a patient in need thereof by administering botulinum toxin to the patient’s nerves. Additionally, the prior art demonstrates that direct administration of botulinum toxin to the tissue around the heart may treat arrhythmias such as atrial fibrillation but researchers such as those at Duke University found no statistically significant correlation between botulinum toxin administration and resolution of atrial fibrillation (an arrythmia). This at least lends itself to the unpredictability of treating arrythmias in a patient in need thereof with botulinum toxin.
Because none of the prior art teaches applicant’s claimed invention, a person having ordinary skill could look only to applicant’s disclosure to enable the claimed invention. In this case, as discussed above, applicant has provided only one patient who has undergone the claimed method and the treatment for this patient involved a very narrow application of applicant’s methods (detailed above). Accordingly, given the lack of prior disclosure and Duke University’s conclusion that direct administration of botulinum toxin to the affected area did not necessarily resolve arrythmias, there is a low level of predictability that applicant’s methods could be used to “treat” arrythmias in the narrowest methodology (the specific injection sites cited in the working example) let alone with any administration of any botulinum toxin to any dermatome. Applicant’s own methods contemplate the failure for the claimed method to sufficiently treat the arrythmia by reciting “wherein if the patient's neuroexcitatory substances level fails to normalize, an antagonist to the neuroexcitatory substances is administered to the patient” (claim 17) (i.e., if the method fails to treat the arrythmia, the patient is administered an unrelated antagonistic therapy). Additionally, the claims allow for injection to only one site (by virtue of the use of “and/or” before the final nerve in line 7) while the specification, as discussed above, explicitly teaches a need to inject “not only to the directly involved dermatomes but also the rest of the sensory dermatomes because if these areas are overproducing the excitatory neural peptides, they can diffuse up and down the spinal cord and produce overstimulation of other nerves by a process called central stimulation” (Specification, p. 22, par. 2). As demonstrated by Pokushalov, it was known in the art that post-operative arrythmias can be spontaneously resolved, even at 2 ½ post-op (p. 1338, Figure 3). Thus, because of this knowledge and applicant’s lack of disclosure of testing steps such as monitoring neuroexcitatory substance levels in the patient, there is a high level of experimentation needed to determine which, if any, amounts of botulinum neurotoxin and administration regimens are capable of “treating” arrhythmias over the entire breadth of the term as defined by applicant’s disclosure.
Conclusion
Upon consideration of the Wands factors and the evidence as whole, the claims fully lack enablement because even in their most narrow form, applicant has not sufficiently demonstrated methods to treat arrhythmia (e.g., prophylactically, preventatively, or therapeutically) by administering botulinum toxin. Similarly, in their broadest scope, the prior art demonstrates that no method of treating arrhythmia with botulinum toxin can be performed without undue experimentation given the lack of significant difference in arrythmia incidence after botulinum toxin administration.
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.
Previous double patenting rejections
RE: Rejection of claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,960,060 B1 in view of Purkiss et al. (Biochemical Society Transactions, 1998, Vol. 26, Article 140, page S108).
Without acquiescing to the merits of the rejection of record, applicant has filed a Terminal Disclaimer over the ‘060 patent. The terminal disclaimer was approved on 05/29/2026. Accordingly, the rejection for double patenting has been withdrawn.
Conclusion
No claim is allowed.
All claims are identical to or patentably indistinct from or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRANT C CURRENS/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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