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
The instant application, filed 08/07/2025, is a national stage entry of PCT/US2022/026143, filed 04/25/2022, and a continuation of 18/559,705, which claims domestic priority to U.S. provisional application no. 63/179, 885, filed 04/26/2021.
Amendments and Claim Status
The following amendment filed on 06/01/2026 is acknowledged and entered.
Claims 1 and 2 are amended;
Claims 3-5, 10, 17-19, and 21 are cancelled;
Claims 13-16 remain withdrawn according to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species;
Claims 1, 2, 6-9, 11-16, and 20 are pending and are under prosecution.
Information Disclosure Statement
The Information Disclosure Statement filed on 06/01/2026 is acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statement is considered.
Response to arguments
Applicant’s arguments filed 06/01/2026 with respect to the objection to the drawings, and rejections under 35 U.S.C. § 103 and nonstatutory double patenting have been fully considered.
With respect to the objection to the drawings, the amendment to Figures 15A and 15B are sufficient to overcome the objection. Accordingly, the objection is hereby withdrawn.
With respect to the rejection of claims 1, 2, 5-9, 11, and 19-21 under 35 U.S.C. § 103 as being unpatentable over Baltezor et al. (US 20190022081 A1, published January 27, 2019, cited in applicant IDS filed 08/07/2025), hereinafter Baltezor, the arguments made by Applicant have been fully considered, but are not persuasive. The arguments made by Applicant are herein addressed as follows.
Applicant argues that Baltezor fails to teach or suggest cisplatin particles having the claimed SSA, because the reference fails to teach any cisplatin particles, and the only particles actually produced and exemplified are taxane particles.
Applicant’s argument is unpersuasive because Baltezor is not limited to its working examples. Baltezor expressly and unambiguously names cisplatin as a member of the disclosed genus of chemotherapeutic agents in a limited number of species. According to MPEP §2123, patents are relevant as prior art for all they contain. That is, the references available for all that it teaches, not merely its preferred or exemplified embodiments. The disclosed alternative of cisplatin is made available to a person of ordinary skill in the art by the disclosure of Baltezor. The guidance to produce the particles with the instantly claimed SSA and sized dimensions is sufficiently present in the disclosure, and constitutes a case of prima facie obviousness.
Applicant references the affidavit submitted by Michael Baltezor, which argues that the high mean bulk density of the unprocessed cisplatin particles made the preparation of a stable, uniform particle composition very difficult. Applicant argues that a person of ordinary skill in the art would understand that different compounds will process differently in an unpredictable and non-obvious way.
Applicant’s argument and affidavit is unconvincing, because the instant claims are drawn to a pharmaceutical composition, and not a process of producing the particles. A Showing of difficulty in a process of producing the composition is not equivalent to a showing of nonobviousness or unpredictability sufficient to rebut a prima facie case of obviousness. Challenges presented in processing amount to routine optimization, and do not confer patentability. According to MPEP 2144.05 II A,
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Baltezor clearly provides sufficient guidance to a person of ordinary skill in the art for producing chemotherapeutic particles across the recited SSA and bulk density ranges. The mere fact that starting bulk density differ between cisplatin and taxane does not establish that arriving at the claimed particle characteristics required more than routine experimentation, particularly absent a showing of any unexpected results or direct comparison with the prior art.
As such, Baltezor provides sufficient guidance for a person of ordinary skill in the art to arrive at the instant claims with a reasonable expectation of success. The original rejection is amended only to account for the new limitations now added to independent claim 1. The grounds of the rejection and application of the teachings of Baltezor remain the same.
Accordingly, the rejection under 35 U.S.C. § 103 is deemed proper and hereby maintained.
With respect to the rejection of claim 12 under 35 U.S.C. § 103 as being unpatentable over Baltezor (as applied to claims 1, 2, 5-9, 11, and 19-21 above) in view of Kosmidis et al. (Int J Mol Sci, Volume 20, Issue 8, published April 24, 2019), hereinafter Kosmidis, the arguments made by Applicant have been fully considered, but are not persuasive. The arguments made by Applicant are herein addressed as follows.
Applicant argues that Kosmidis does not overcome the deficiencies of Baltezor with respect to claim 12, because the alleged deficiencies (failure to teach cisplatin particles with the claimed SSA) are not remedied by Kosmidis.
Applicant’s argument is unpersuasive because the argument is entirely dependent on and derivative of the underlying arguments against Baltezor, which are deemed unpersuasive for the reasons set forth above. As Baltezor is found to render obvious the limitations of the claim 1, from which claim 12 depends, the argument is considered moot.
As a statement for the record, applicant has not separately addressed what Kosmidis teaches, or what combination with the teachings of Baltezor would have been improper.
Accordingly, the rejection under 35 U.S.C. § 103 is deemed proper and hereby maintained.
With respect to the provisional rejection of claims 1, 2, 5-9, 11, 12, and 19-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-9, 15, 16, 18, 20, 22- 26 of copending Application No. 18/492,232, (US 20240156861 A1) in view of Kosmidis (see earlier citation), claims 15, 16, 18, 20, 22- 26 of the co-pending application have been canceled in the claim amendment filed 04/17/2026. With respect to the provisional rejection of claims 1, 2, 5-9, 11, 12, and 19-21 on the ground of nonstatutory double patenting as being unpatentable over claim 1-9, 11, and 12 of copending Application No. 18/556,705, (US 20240216424 A1), claims 1-9, 11, and 12 of the co-pending application have been canceled in the claim amendment filed 04/23/2026. With regard to the remaining co-pending claims in both applications, the arguments made by Applicant have been fully considered but are not persuasive. The arguments made by Applicant are herein addressed as follows.
With regard to co-pending application 18/492,232, Applicant acknowledges the rejection and will consider whether filing a terminal disclaimer is needed, once the pending claims are otherwise allowable.
Applicant’s arguments regarding the previously addressed 35 U.S.C. § 103 rejection are not convincing, and the claims are not deemed to be allowable. In order to overcome the double patenting rejection, Applicant should file a terminal disclaimer. The nonstatutory double patenting rejection against the claims which remain in the co-pending application are not overcome by amendment, and are hereby maintained.
With regard to co-pending application 18/556,705, Applicant argues that the requirement for restriction has withdrawn the method for making compound particles in the instant application.
Applicant’s argument is unconvincing because the co-pending application recites a method for making the instantly claimed compound particles, which overlap in scope with that which is claimed. That is, co-pending method for making compound particles necessarily produces the particles instantly claimed. Therefore, the claims overlap in scope. Furthermore the instant application was filed as a continuation, rather than a divisional of the parent application. As set forth in MPEP § 804.01, the prohibition of rejections which arises under 35 U.S.C. § 121 against using a restricted invention as a double patenting reference applies only to divisional applications filed as a result of the restriction requirement—not to continuations.
A nonstatutory double patenting rejection may also be avoided if consonance between the originally restricted inventions is maintained in a divisional application. "Section 121 shields claims against a double patenting challenge if consonance exists between the divided groups of claims and an earlier restriction requirement." Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1381, 68 USPQ2d 1865, 1871 (Fed. Cir. 2003). "Consonance requires that the line of demarcation between the ‘independent and distinct inventions’ that prompted the restriction requirement be maintained.
Because the parent application remains pending, Applicant may file concurrently a request to change the relationship of the instant application from a continuation to a divisional of the parent application in order to overcome the double patenting rejection on the grounds of the restriction requirement. Applicant is advised that this redesignation can only be made while the parent application is still pending.
In addition, Examiner submits that co-pending claim 17 was erroneously omitted from the listing of the previous nonstatutory double patenting rejection. The nonstatutory double patenting rejection is thus amended to cover claim 17 in the co-pending application. The rejection is hereby amended, and maintained.
Thus, all arguments presented by Applicants have been addressed and are found unpersuasive for the reasons presented herein and in the previous non-final rejection. Applicants are reminded that “attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Status of Claims
Claims 1, 2, 6-9, 11-16, and 20 are pending in the instant application. Claims 13-16 remain withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1, 2, 6-9, 11, 12 and 20 read on an elected invention and species and are therefore under consideration in the instant application.
Drawings
The drawings filed on 06/01/2026 are found to be in compliance with 37 CFR §§ 1.121 and 1.84, and are hereby accepted.
Claim interpretation
Claim 21 is interpreted to be canceled, as the identifier of the claim designates it as such. The limitations of the claim have been added to the definition of independent claim 1. As such, under the broadest reasonable interpretation set forth by MPEP § 2111, claim 21 is hereby interpreted to be canceled.
Claim Objections
Claim 21 is objected to for the following informalities:
According to MPEP § 714 II. C. (A), a proper identifier identifying the status of the claim, and reflecting the history of its presentation and amendment, must be present. The MPEP guidance states,
Claims added by a preliminary amendment must have the status identifier (new) instead of (original), even when the preliminary amendment is present on the filing date of the application and such claim is treated as part of the original disclosure. If applicant files a subsequent amendment, applicant must use the status identifier (previously presented) if the claims are not being amended, or (currently amended) if the claims are being amended, in the subsequent amendment. Claims that are canceled by a preliminary amendment that is present on the filing date of the application are required to be listed and must have the status identifier (canceled) in the preliminary amendment and in any subsequent amendment.
Presently, claims 21 is designated as “Canceled” but includes the limitations associated with the previously defined claim. In order to be consistent with the other canceled claims, the claim limitations should be removed so that they are not erroneously determined to be under consideration.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 6-9, 11, and 20 are rejected under 35 U.S.C. § 103 as being unpatentable over Baltezor et al. (US 20190022081 A1, published January 27, 2019, cited in applicant IDS filed 08/07/2025), hereinafter Baltezor.
The instant claims are drawn to a pharmaceutical composition comprising cisplatin particles that have a specific surface area (SSA) elected to be 3.5 m2/g and preferably the range of 3.5 m2/g and about of 30 m2/g.
Baltezor teaches a pharmaceutical composition (paragraph [0212]) used in a method for solid tumor treatment. The composition comprises chemotherapeutic particles (claim 1) which include cisplatin (claim 11, see instant claim 1). The chemotherapeutic particles comprise at least 95% chemotherapeutic have a specific surface area (SSA) of between about 10 m2/g and about 50 m2/g (claim 21, see instant claims 1 and 2). The prior art further discloses that the chemotherapeutic particles are between 0.1 μm and 5 μm in diameter (paragraph [0153], see instant claim 1). Baltezor further teaches wherein the particles comprise at least 96%, 97%, 98%, 99%, or 100% of the chemotherapeutic compound (paragraph [0079], see instant claims 1 and 7) that are between 0.1 μm and 5 μm in diameter (paragraph [0153], see instant claim 1). The prior art discloses wherein the particles are uncoated and the suspension or kit excludes polymers, proteins, polyethoxylated castor oil, and/or polyethylene glycol glycerides composed of mono-, di- and triglycerides and mono- and diesters of polyethylene glycol (paragraph [0138], see instant claim 8). The prior art further teaches a suspension further comprising a pharmaceutically acceptable liquid carrier (paragraph [0139], see instant claim 9). Finally, the prior art discloses wherein the composition may be in the form of a powder, and teaches wherein lower powder bulk densities yield faster dissolution rate (paragraph [0166]), and teaches a specific embodiment wherein a chemotherapeutic particle is in the form of a powder for suspension ([0373, [0376]).
Regarding claim 1, Baltezor expressly identifies cisplatin as one of the chemotherapeutic agents within the disclosed group of chemotherapeutic agents (claim 11). As such, a prima facie case of obviousness is established because picking one of a finite number of known solutions to a known problem is prima facie obvious. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). That is, cisplatin is explicitly contemplated as part of the claimed subject matter, and therefore selection of cisplatin from the expressly disclosed group constitutes more than the predictable selection of a disclosed species from a finite number of identified options, which is considered prima facie obvious.
Further regarding claims 1, 2, 6-9, 11, and 20, the instantly claimed ranges overlap with those taught by the prior art. Regarding claims 1 and 2, and the specific recitation of a specific surface area range between 3.5 m2/g and about of 30 m2/g (claim 1) and between 7 m2/g and about of 30 m2/g (claim 2), the prior art teaches wherein the SSA of the chemotherapeutic particles disclosed is 10 m2/g and about 50 m2/g (claim 21, see instant claims 1 and 2). Regarding claim 1 which recites a specific mean particle size by volume distribution, the prior art further discloses that the chemotherapeutic particles are between 0.1 μm and 5 μm in diameter (paragraph [0153], see instant claim 1). Baltezor further teaches wherein the particles comprise at least 96%, 97%, 98%, 99%, or 100% of the chemotherapeutic compound (paragraph [0079], see instant claim 6) that are between 0.1 μm and 5 μm in diameter (paragraph [0153], see instant claim 1). Regarding claims 6 and 20, which recite a specific mean bulk density of 0.02 g/cm3 to about 0.8 g/cm3, the prior art teaches wherein the chemotherapeutic particles have a mean bulk density between about 0.050 g/cm3 and about 0.15 g/cm3, and/or a specific surface area (SSA) of at least 18 m2/g (paragraph [0166]). Thus, the ranges taught by the prior art overlap with those of the instant claims. With regard to overlapping ranges, it is noted that the courts have stated,
where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that,
“where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant of the values of the cited prior art.
Regarding, claim 11, wherein the suspension is aerosolized with a median aerodynamic diameter of aerosol droplets at about 0.5 mm to 6 mm, this is merely a recitation of intended use of the composition already taught by the prior art. The prior art teaches a suspension having the same characteristics as that of the instant claims. As such, the prior art suspension is necessarily capable of the claimed intended use. According to MPEP § 2112.01 (I), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. The courts have stated
In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." See In re Spada "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
Therefore, because the prior art teaches a suspension having the same characteristics and claimed compositional features, it is capable of the intended use—being aerosolized to produce droplets within the recited media and aerodynamic diameter range. Accordingly, the prior art satisfies the limitations of the claim although not explicitly recited in the prior art.
Claim 12 is rejected under 35 U.S.C. § 103 as being unpatentable over Baltezor (as applied to claims 1, 2, 6-9, 11, and 20 above) in view of Kosmidis et al. (Int J Mol Sci, Volume 20, Issue 8, published April 24, 2019), hereinafter Kosmidis.
Baltezor is as set forth above.
Baltezor does not specifically exemplify cisplatin as a dry powder composition capable of being aerosolized with a specific mass median aerodynamic diameter (MMAD).
However, as detailed above Baltezor specifically teaches that the formulation, wherein the active chemotherapeutic agent may be selected as cisplatin, is prepared as a dry powder formulation [0166]. Thus the dry powder formulation of Baltezor which comprises cisplatin as the chemotherapeutic particles is necessarily capable of being aerosolized as claimed in claim 12.
In addition, Kosmidis, teaches inhaled cisplatin administration for lung cancer (Abstract, Table 1). Kosmidis teaches wherein the cisplatin particles may be in the form of dry powder that may be aerosolized (Table 1, see instant claim 12). Kosmidis teaches wherein the optimal mass media and aerodynamic diameter (MMAD) for deep lung penetration is between 3-5 µm (page 5, see instant claim 12).
One of ordinary skill in the art prior to the effective filing date of the instant claims would have been motivated to select cisplatin from Baltezor’s disclosed chemotherapeutic genus in order to optimize the particle aerodynamic properties consistent with inhalation parameters expressly taught by Kosmidis to achieve effective systemic distribution. The combination of chemotherapeutic particle engineering teachings to the known inhalation cisplatin delivery parameters disclosed by Kosmidis would yield a predictable expectation of success in the use of said particles as a cancer therapeutic, as taught by both Baltezor and Kosmidis.
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, 2, 6-9, 11, 12, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4-9 of copending Application No. 18/492,232, (US 20240156861 A1) in view of Kosmidis (as applied to instant claim 12, above). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims teach the composition as instantly claimed.
The co-pending application fails to teach specific MMDA values of cisplatin particles.
The deficiencies of the co-pending application are remedied by Kosmidis teaches wherein the cisplatin particles may be in the form of dry powder that may be aerosolized (Table 1, see instant claim 11). Kosmidis teaches wherein the optimal mass media and aerodynamic diameter (MMAD) for deep lung penetration is between 3-5 µm (page 5, see instant claims 11 and 12).
Regarding instant claim 1, co-pending claims 1, 2, 4, and 5 teach a suspension and/or dry powder composition comprising cisplatin particles were in the particles include at least 95% by weight cisplatin with a specific surface area that falls within the instantly claimed SSA. Furthermore, co-pending claim 6 teaches wherein the mean particle size by volume distribution is within the instantly claimed ranges.
Regarding instant claim 2, co-pending claim 5 teaches wherein the particles may have a specific surface area within the instantly claimed range.
Regarding instant claims 6 and 20, the co-pending claim 7 teaches wherein the particles have a mean bulk density within the instantly claimed range.
Regarding instant claim 7, co-pending claim 8 teaches wherein the particles comprise at least 98% by weight cisplatin.
Regarding instant claim 8, co-pending claims 9 teaches wherein the particles are uncoated and exclude the same components as instantly claimed.
Regarding instant claim 9, co-pending claims 1, 2, 4, and 5 teach a suspension further comprising a pharmaceutically acceptable carrier.
Regarding instant claims 11 and 12, Kosmidis teaches wherein the optimal mass media and aerodynamic diameter (MMAD) for deep lung penetration of cisplatin dry powder particles is between 3-5 µm (page 5, see instant claims 11 and 12).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. If a notice of allowance is issued in the co-pending application 18/492,232 upon issue of the patent, the provisionary NSDP rejection over the co-pending application will convert to a NSDP rejection over the published patent.
Claims 1, 2 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of copending Application No. 18/556,705, (US 20240216424 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims teach the composition as instantly claimed.
Regarding instant claims 1, 2, and 12 co-pending claim 17 teach a method for making compound particles were in the particles produced include at least 95% by weight cisplatin with a specific surface area and particle sizes that fall within the instantly claimed ranges. That is, the method that is claimed in the co-pending application would necessarily produce the composition instantly claimed.
Although the instantly claimed composition under examination and the method of making the composition of the co-pending claim 17 were indeed restricted in the parent case, the protection against double patenting rejection does not apply in the instant case, because the instant application has been filed as a continuation to the parent application, and not as a divisional which is protected under 35 U.S.C. § 121. Applicant may change the relationship of the instant application to the parent to be a divisional application instead of a continuation. Applicant is advised that this redesignation can only be made while the parent application is still pending.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. If a notice of allowance is issued in the co-pending application 18/556,705, upon issue of the patent, the provisionary NSDP rejection over the co-pending application will convert to a NSDP rejection over the published patent.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (571) 273-8300.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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