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 .
Status of the Claims
Acknowledgement is made of the response filed on August 6, 2026. In that response, claims 23, 29, 31, and 33 were amended and claims 28, 30, 32, 37, and 38 were cancelled. Claims 23-27, 29, 31, and 33-36 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 26 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 26 recites a limitation now recited in claim 23. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 23-27, 29, 31, and 33-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 23 recites a tablet composition comprising “at least 40%... of darolutamide or a pharmaceutically acceptable salt thereof, 25-50% per weight of the composition, of a filler;…having a compact tensile strength of at least about 3.5 MPa at average punch pressure of 200 MPa”. The specification does not adequately describe representative tablet compositions or any relevant, identifying characteristics, including the recited concentration ranges of the active agent and each excipient, regarding the compact tensile strength of at least about 3.5 MPa at average punch pressure of 200 MPa.
The methodology for determining adequacy of written description entails (1) for each claim, determining what the claim as a whole covers, (2) reviewing the entire application to understand how applicant provides support for the claimed invention including each element and/or step, and (3) determining whether there is sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed. MPEP §2163(II). Also the “written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice …, reduction to drawings …, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” MPEP §2163(II)(A)(3)(a)(ii) (citations omitted). The “Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed’.” Id. (citations omitted).
1) Claim 23 as a whole covers any tablet composition comprising 40% or more of darolutamide or a salt thereof and a total of 26.2-69% by weight of excipients (a filler, disintegrant, binder, and lubricant), and having at least about 3.5 MPa compact tensile strength at average punch pressure of 200 MPa. The claims encompass any salt of darolutamide. Claim 23 does not limit any of the excipients to any particular compounds. Claims 27, 29, 31, and 33 each recite a specific filler, disintegrant, binder, or lubricant. No claim recites lactose monohydrate.
(2) The entire application has been reviewed to understand support for the claimed invention including each element. The disclosure contains example tablet formulations of darolutamide (all using milled darolutamide as the tablet core), but the tensile strength is disclosed for only one, “A-darolutamide”, in Example 6 (paras. 0047-57, pre-grant publication US 2022/0362216). “A-darolutamide” comprised 300 mg milled darolutamide combined with five specific excipients, each in specific quantities (Table 1, para. 0047). The preparation process involved milling the darolutamide, wet granulation with water, followed by drying, among others.
Notably, replacing lactose monohydrate with microcrystalline cellulose (“B-Darolutamide”) resulted in a compact tensile strength below 3.5 MPa at 200 MPa average punch pressure (Fig.2, paras.0056-57). The disclosure does not disclose any other example formulations and its compact tensile strength, including the effects of excipients and their concentration, e.g., microcrystalline cellulose in place of lactose monohydrate.
Also while the “A-darolutamide” formulation resulted in tensile strength above 3.5 MPa from both slow and fast compression speeds, a formulation that is identical but for including paracetamol in lieu of milled darolutamide (Table 1, the middle column between A- and B-Darolutamide), resulted in low tensile strength. “Comparison to a similar composition but having a model drug (paracetamol) as an active ingredient shows that the same composition used with another drug substance did not produce tablets with acceptable tensile strength within compression force range appropriate for tablet production.” (Specification para.0056; See Fig.1). Whether the contrasting compact tensile strengths arise from the active agent or the milling not disclosed.
There is no discussion of how the different salts, the lack of a milling step for the active agent, or different excipients, e.g., microcrystalline cellulose in place of lactose monohydrate, affect the “compact tensile strength of at least about 3.5 MPa at average punch pressure of 200 MPa”. This is an instance wherein “a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed’” MPEP §2163(II)(A)(3)(a)(ii) (citations omitted).
(3) Therefore it is determined that there is not sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed.
Response to Arguments
Although the above rejection has been modified to reflect claim amendments Applicant’s arguments are addressed now to the extent they have not been rendered moot and are relevant to the above rejections.
Applicant's arguments filed August 6, 2026 have been fully considered but they are not persuasive. Applicant argues that the specification reasonably conveys possession of the full scope of the claimed subject matter because Example 6 describes the A-darolutamide tablet composition which achieved the claimed compact ensile strength, Examples 1, 4, and 5 describe the suitable excipients, and the specification states, “that these compositions ‘provide[] excellent tabletability of the tableting mass, good resistance to crushing and low brittleness enabling manufacture of the tablets in large industrial scale”. (Remarks, 5, August 6, 2026, citing Specification at 2 ll. 17-19).
In response it is noted that the sole mention of the compact tensile strength concerns A-Darolutamide in Example 6. Example 6 also illustrates that replacing lactose monohydrate with microcrystalline cellulose (“B-Darolutamide”) resulted in a compact tensile strength below 3.5 MPa at 200 MPa average punch pressure (Fig.2, paras.0056-57). Example 6 still further illustrates that a medicament different from milled darolutamide but including lactose monohydrate also results in low compact tensile strength. In light of these it is questionable whether the formulations of Examples 1, 4, and 5, which contained excipients and concentrations different from A-Darolutamide, exhibited tensile strength of at least about 3.5 MPa. Moreover there is no disclosure that permits some extrapolation of the concentrations in the A-Darolutamide formulation to the ranges in claim 23.
Claim Rejections - 35 USC § 103
The following is a quotation of 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 23-27, 29, 31, and 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Dervan (US 2018/0064688) in view of PharmaState Academy (Excipients used in tablets, available at https://pharmastate.academy/excipients-used-in-tablets/ Aug. 14, 2017, accessed on July 9, 2025) and Varma (Varma, K.V., Excipients used in the Formulation of Tablets, Research and Reviews: Journal of Chemistry, Vol. 5 June 2016) as evidenced by Rother (WO 2014/128107A1).
Dervan teaches pharmaceutical compositions, including tablets, comprising darolutamide, alone or in a combination (title; abstract; paras.0009, 0034, 0073, 0085, 0089, 0101; claims 1, 4, 6, 19, 21). A single dose is preferably 300-600 mg (para.0073). Dervan further teaches fillers including lactose, disintegrants including cross-linked sodium carboxymethyl cellulose or croscarmellose sodium, binders including polyvinyl pyrrolidone, and lubricants including magnesium stearate (paras. 0087, 0101).
Regarding “at least about 3.5 MPa compact tensile strength at average punch pressure of 20 MPa”, the following is noted:
Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect:
(A) statements of intended use or field of use, including statements of purpose or intended use in the preamble,
(B) "adapted to" or "adapted for" clauses,
(C) "wherein" or "whereby" clauses,
(D) contingent limitations,
(E) printed matter, or
(F) terms with associated functional language.
This list of examples is not intended to be exhaustive... For more information about these types of claim language and how to determine whether they have a limiting effect on claim scope, see MPEP §§ 2111.02 through 2111.05.
MPEP §2103(I)(C) (emphases added). Here the claim phrases do not require the particular structure, e.g., the particular excipients, their concentrations, and method of preparation such as the milling of the darolutamide and the wet granulation disclosed, to obtain the functions and properties recited in the clauses. Claim 23 encompasses any tablet composition that comprises at least 40% by weight of darolutamide or a salt thereof and a total of 26.2-69% by weight of excipients (a filler, disintegrant, binder, and lubricant). Claim 23 does not limit any of the excipients to any particular compounds. Thus the phrases do not limit the scope of the claim and are not afforded patentable weight.
Regarding claim 34, Dervan teaches the pharmaceutical compositions “can be manufactured by methods well known in the art such as conventional granulating, mixing,…” (para.0089). Furthermore the “patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP §2113 (citations omitted).
Dervan does not specifically teach the weight concentrations of darolutamide and of each excipient, and the calcium hydrogen phosphate in claims 23-27, and 34, or the intra and extragranular structure in claim 35.
PharmaState Academy and Varma are drawn to excipients commonly used in pharmaceutical tablets, and teaches those in claims 27, 29, and 33. Diluent or filler includes lactose and dibasic calcium phosphate dihydrate (PharmaState Academy p.1, Varma p.143) which is a “calcium hydrogen phosphate” according to Applicant (para.0015, pre-grant publication US 2022/0362216). Its concentration would depend on the size of the composition or dosage form. Disintegrants include croscarmellose sodium of which a portion “is added before granulation and a portion before compression, which serve as glidants or lubricant” (PharmaState Academy p.2). Croscarmellose sodium is used in “tablets in the concentration of 0.5 to 5.0%” (Varma p.146) which range is within that in claim 23. Binders include polyvinylpyrrolidone at 2% (PharmaState Academy p.1) which is within the range in claim 23. Lubricants include magnesium stearate which is used in “tablet manufacture at concentration between 0.25 – 0.5% w/w” (Varma p.148) which range is within that in claim 23.
Rother evidences prior art knowledge on tablet formulations using each of these excipients according to the desired tablet features such as the size and release profile. Rother teaches pharmaceutical compositions comprising 30-60% by weight of an active agent (title; abstract; p.11 last para.-p.12 second full para.; claims 1-6), polyvinylpyrrolidone binder preferably at 5-10% by weight of the composition, croscarmellose sodium disintegrant at 0.5 to 8%, magnesium stearate lubricant at 0.5 to 2% by weight (p.3 second para.-p.4 second para.), calcium hydrogen phosphate at 10-20%, and lactose at 10-20% by weight (p.4 fifth-sixth paras.). These ranges overlap the corresponding ranges in claims 23-25.
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Dervan, PharmaState Academy, and Varma, and devise a pharmaceutical composition comprising darolutamide and each of the excipients in the concentrations recited as has been done in Rother. The skilled person would have been suggested to do so because all references are drawn to pharmaceutical tablet compositions comprising an active agent, Dervan specifically teaches using lactose, croscarmellose sodium, polyvinylpyrrolidone, and magnesium stearate, with darolutamide, and PharmaState Academy and Varma teach the weight concentrations ranges for the excipients. The selection of a known material or mechanism based on its suitability for its intended use supports a prima facie obviousness determination. MPEP §2144.07 (citations omitted). Furthermore for result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted), and optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Response to Arguments
Applicant's arguments filed August 6, 2026 have been fully considered but they are not persuasive. Applicant argues that both PharmaState and Varma show that formulation science is not predictable, as here demonstrated, “that properties of pharmaceutical compositions do not automatically translate from one active ingredient to another” as between darolutamide and paracetamol in Example 6. (Remarks, 7, August 6, 2026.)
In response, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here Dervan teaches pharmaceutical compositions, including tablets, comprising darolutamide, alone or in a combination (title; abstract; paras.0009, 0034, 0073, 0085, 0089, 0101; claims 1, 4, 6, 19, 21). A single dose is preferably 300-600 mg (para.0073). Dervan further teaches fillers including lactose, disintegrants including cross-linked sodium carboxymethyl cellulose or croscarmellose sodium, binders including polyvinyl pyrrolidone, and lubricants including magnesium stearate (paras. 0087, 0101). While PharmaState and Varma note the importance of combining a drug with each of the excipients, Dervan teaches the particular excipients recited in the dependent claims here. Therefore the skilled person could look to general guidance in PharmaState and Varma with reasonable expectation of success.
Applicant next argues that Dervan does not teach any specific formulation and the Office has not established a motivation to combine it with PharmaState and Varma because Derman is drawn to combination therapy for prostate cancer whereas the former are general-purpose guides. (Remarks, 7-8, August 6, 2026.)
However the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here the Dervan specifically teaches using lactose, croscarmellose sodium, polyvinylpyrrolidone, and magnesium stearate, with darolutamide, and PharmaState Academy and Varma teach the weight concentrations ranges for those same excipients. The selection of a known material or mechanism based on its suitability for its intended use supports a prima facie obviousness determination. MPEP §2144.07 (citations omitted).
Applicant next contends that the skilled person would not have had a reasonable expectation of success in arriving at a darolutamide composition having a compact tensile strength of at least about 3.5MPa at an average punch pressure of 200 MPa, which limitation should be entitled to patentable weight. (Remarks, 9-10, August 6, 2026.).
However “at least about 3.5 MPa compact tensile strength at average punch pressure of 20 MPa”, suggests the features of the A-Darolutamide in Example 6, i.e., milled darolutamide, the specific excipients and concentrations. However none of the present claims, i.e., does not require, those features. A-Darolutamide is the only formulation disclosed that actually attained the recited compact tensile strength, and replacing the lactose monohydrate with the microcrystalline cellulose in B-darolutamide resulted in a low compact tensile strength below 3.5 MPa. Therefore the “wherein the tablet composition has a compact tensile strength…” does not limit the scope of the claims and is not afforded patentable weight.
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 23-27, 29, 31, and 33-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12329742.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a tablet composition comprising at least 40% per weight of the composition, of darolutamide or a pharmaceutically acceptable salt thereof, and
overlapping weight concentrations of fillers, overlapping weight concentrations of a disintegrant, overlapping weight concentrations of a binder, and overlapping weight concentrations of a lubricant. The ‘742 patent’s claims further recite specific excipients and concentrations of the excipients which are narrower than those in the present claims. The present claims recite compact tensile strength of at least about 3.5 MPa at average punch pressure of 200 MP. However for product claims, “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent”. MPEP §2112.01(I). Furthermore a “chemical composition and its properties are inseparable”. MPEP § 2112.01(II). Therefore the tablets of the ‘742 patent’s claims would have had the recited compact tensile strength.
Claims 23-27, 29, 31, and 33-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 19631254 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a tablet composition comprising at least 40%, per weight of the composition, of darolutamide or a pharmaceutically acceptable salt thereof, and
overlapping weight concentrations of fillers, overlapping weight concentrations of a disintegrant, overlapping weight concentrations of a binder, and overlapping weight concentrations of a lubricant. The ‘254 application’s claims further recite concentrations of the excipients which are only slightly broader than those in the present claims. The present claims recite compact tensile strength of at least about 3.5 MPa at average punch pressure of 200 MP. However for product claims, “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent”. MPEP §2112.01(I). Furthermore a “chemical composition and its properties are inseparable”. MPEP § 2112.01(II). Therefore the tablets of the ‘254 application’s claims would have had the recited compact tensile strength.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed August 6, 2026 have been fully considered but they are not persuasive. Applicant argues that in the parent application 17/623922 which matured to U.S. Patent 12329742, a restriction was required among Groups A through F, among which Applicant elected Group A, this application was filed to pursue Group C and the ‘254 application to pursue Group B, Applicant timely filed this divisional application, and therefore the safe harbor protections of 35 U.S.C. 121 should apply to the present claims. (Remarks, 11-12, August 6, 2026.)
However the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply when the “claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made" MPEP §804.01. The restriction requirement in application 17/623922 concerned species of tablet compositions comprising at least 35% darolutamide or a pharmaceutically acceptable salt thereof. The present claims now (amended August 6, 2026) require substantially overlapping weight concentrations for each of darolutamide or a pharmaceutically acceptable salt thereof, fillers, a disintegrant, a binder, and a lubricant as in Group A. The claims of the ‘254 application also recites overlapping concentrations of the active agent and the excipients, unlike in Group B of the parent application.
Therefore the claims here and in the ‘254 application have been changed in material respects from the claims at the time the requirement was made and are no longer consonant with restriction requirement in the parent application.
CONCLUSION
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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