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 .
Election/Restrictions
Applicant’s election in the reply filed on 6/3/2025 is acknowledged:
PNG
media_image1.png
262
654
media_image1.png
Greyscale
Claims 1, 3-8 cover the elected species. Claim 2 is withdrawn from consideration as exclusively covering a non-elected invention.
Claim Rejections - Rejection under the Judicially Created Doctrine of Improper Markush Grouping
Claims 1 and 3-8 are rejected under the judicially created doctrine of "improper Markush grouping". The Markush group of Formula (VIII) contains a plethora of nested variables. This is an improper grouping of alternatively useable species. MPEP 803.02 describes a Markush grouping as " ... "selected from the group consisting of A, Band C." The examiner respectfully directs the Applicant's attention to MPEP 803.02 shown below for convenience:
"A Markush-type claim recites alternatives in a format such as "selected from the group consisting of A, Band C." See Ex parte Markush, 1925 C.D. 126 (Comm'r Pat. 1925). The members of the Markush group (A, B, and C in the example above) ordinarily must belong to a recognized physical or chemical class or to an art-recognized class. However, when the Markush group occurs in a claim reciting a process or a combination (not a single compound), it is sufficient if the members of the group are disclosed in the specification to possess at least one property in common which is mainly responsible for their function in the claimed relationship, and it is clear from their very nature or from the prior art that all of them possess this property. Inventions in metallurgy, refractories, ceramics, pharmacy, pharmacology and biology are most frequently claimed under the Markush formula but purely mechanical features or process steps may also be claimed by using the Markush style of claiming. (See MPEP § 2173.05(h))."
Furthermore, the members of a proper Markush grouping " ... ordinarily must belong to a recognized physical or chemical class or to an art-recognized class." MPEP 803.02 also states that members of a Markush grouping are " ... sufficiently few in number or so closely related that a search and examination of the entire claim can be made without serious burden." This paragraph of the MPEP is shown below for convenience: "If the members of the Markush group are sufficiently few in number or so closely related that a search and examination of the entire claim can be made without serious burden, the examiner must examine all the members of the Markush group in the claim on the merits, even though they may be directed to independent and distinct inventions. In such a case, the examiner will not follow the procedure described below and will not require provisional election of a single species. (See MPEP § 808.02.)"
A Markush claim contains an "improper Markush grouping" if:
1. The species of the Markush group do not share a "single structural similarity,"
- Meaning they do not belong to the same recognized physical or chemical class
or same art-recognized class (see explanation supra), or
2. The species do not share a common use,
- Meaning they are not disclosed in the specification or known in the art to be
functionally equivalent.
If 1 or 2 above apply to a Markush grouping, a rejection under the judicially approved "improper Markush grouping" doctrine is proper.
The compounds of Formula (III) do not share a "single structural similarity". For a Markush grouping to be proper, the alternatives represented by the grouping must have a "significant structural element that is shared by all of the alternatives" or the species must all share a common use and recognized as "functionally equivalent". A significant structural element that is shared by all of the alternatives refers to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity. Each alternative does not have a common chemical structure which occupies a large portion of the structure or have a structurally distinctive portion in view of the prior art which is essential to the claimed common activity/properties.
Here there is no common structure that occupies a significant portion of the compounds of Formula (III) since the entire structure is highly variable:
PNG
media_image2.png
126
246
media_image2.png
Greyscale
See definitions in claim 1.
Additionally, as a result of the wide range of compounds possible by the instant Markush formula, each compound does not belong to the same recognized physical or chemical class or to the same art-recognized class and no credible evidence for a common use amongst all claimed compounds exists. A person of ordinary skill in the art would understand that compounds with such greatly varied structure cannot be expected to have predictable properties. This is a central concept to basic organic chemistry and common knowledge of those with ordinary skill in the art and taught in the first chapter of the organic text CAREY, FA. Organic Chemistry 6th Ed. McGraw Hill. 2006, chapter 1, p. 9. Therefore, in the absence of evidence to the contrary, all compounds within the metes and bounds of the extraordinarily large Markush grouping of the instant claims cannot be individually envisioned and each expected to be functionally equivalent.
This rejection may be overcome by either amending the claims to include only the species that share a single structural similarity and a common use such as the compounds which have a constant core and are clearly enabled by the instant specification.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-8 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.
The rejected claims cover conjugates in which every group is highly variable with definitions that allow for combinations of multiple groups:
PNG
media_image2.png
126
246
media_image2.png
Greyscale
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989) (“the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”).
With regard to the recited genus of conjugates, the following applies:
Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010) states that “...a generic claim may define the boundaries of a vast genus of chemical compounds...the question may still remain whether the specification, including the original claim language, demonstrates that the applicant invented species sufficient to support a claim to a genus”. See page 1171.
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. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
See also Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a “laundry list” disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species.
Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) states that “it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it”.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or structural features common to the members of the genus, which features constitute a substantial portion of the genus, so that one of skill in the art can “visualize or recognize” the members of the genus (Emphasis added). Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004)(“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(i), the court states, "An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention."
Courts have stated that “[i]n claims involving [non-genetic] chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus.” Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). (emphasis added).
There is no such specificity here, nor could one skilled in the art identify particular compounds encompassed by the claims. Specifically, Applicant desires patent protection for compounds as having only highly variable groups that comprise an inordinate number of combinations. In view of the above, the specification does not provide adequate written description of the claimed genus of compounds. Specifically, Applicant fails to disclose any other compounds that fall within the genus, besides those species in the specification, e.g., the elected compound, and in relation to the above, these disclosed species do not represent the substantial variety covered by the genus.
With regard to the functional definition of the variables, the specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed (see Vas-Cath at page 1116) because the specification contains almost no information by which a person of ordinary skill in the art would understand that the inventors possessed the all of the recited compounds. As indicated above, a result of the wide range of compounds possible by the instant Markush formula, each compound does not belong to the same recognized physical or chemical class or to the same art-recognized class and no credible evidence for a common use amongst all claimed compounds exists. A person of ordinary skill in the art would understand that compounds with such greatly varied structure cannot be expected to have predictable properties. At best, it simply indicates that one should test an inordinate number of groups to see if the compounds can perform the required therapeutic function, see In re ’318 Patent Infringement Litigation, 583 F.3d 1317, 1327 (Fed. Cir. 2009) (“[A]t the end of the day, the specification, even read in light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient.”).
The Examiner acknowledges that a working example or exemplified embodiment is not necessarily a requirement for description. However, where a generic claim term is present in a claim, as in the present application, and defined only by functional characteristics, the specification must convey enough information, e.g., via sufficient representative examples, to indicate invention of species sufficient to constitute the genus. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 967 2 (Fed. Cir. 2002). The written description requirement “requires a description of an invention, not an indication of a result that one might achieve if one made that invention.” Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997); see also Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1350 (Fed. Cir. 2013) (“A patent...‘is not a reward for the search, but compensation for its successful conclusion.’ ... For that reason, the written description requirement prohibits a patentee from ‘leaving it to the ... industry to complete an unfinished invention.’” (citations omitted)).
Accordingly, the specification lacks adequate written description for the recited genus of conjugates.
Claims 1 and 3-8 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.
The claims have been amended to recite the following genus which does not have support in the originally-filed disclosure:
PNG
media_image2.png
126
246
media_image2.png
Greyscale
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 3-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims recite “composed of” as a traditional phrase, which is the same as “consistently essentially of”, see MPEP 2111.03 (“The transitional phrase "composed of" has been interpreted in the same manner as either "consisting of" or "consisting essentially of," depending on the facts of the particular case. See AFG Industries, Inc. v. Cardinal IG Company, 239 F.3d 1239, 1245, 57 USPQ2d 1776, 1780-81 (Fed. Cir. 2001). However, the structure of the instant compounds are indefinite since Applicant has not defined what is included by this language. Here, “composed of” will be the same as “comprising, see Id. (“…absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising.". However, it is unclear what structures are also included by this interpretation, where “composed of” is the same as comprising. .
Claim 1 recites that W is “normally a…). It is unclear what other structures Applicant intends to cover by this definition.
The structure of the elected species does correspond to the definitions of L1-Q1 or L2-Q2. Therefore, the intended structure of the compounds is unclear.
Claim 1 recites that any one or more of the variables can be independently absent but Q1 and Q2 are not absent at the same time. It is unclear what Q1 or Q2 is bound to, if L1 or L2 is absent.
Claims 1 and 7 recite analogs and derivatives. It is unclear what other structures Applicant intends to cover.
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.
Claims 1 and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/155753 (WO 753).
WO 753 teaches the following compounds:
PNG
media_image3.png
136
546
media_image3.png
Greyscale
See page 21.
See also:
PNG
media_image4.png
498
508
media_image4.png
Greyscale
PNG
media_image5.png
450
498
media_image5.png
Greyscale
PNG
media_image6.png
349
522
media_image6.png
Greyscale
PNG
media_image7.png
398
470
media_image7.png
Greyscale
Specific compounds are given at page 103:
PNG
media_image8.png
82
348
media_image8.png
Greyscale
PNG
media_image9.png
104
460
media_image9.png
Greyscale
PNG
media_image10.png
142
428
media_image10.png
Greyscale
See page 22.
See also compounds at page 82:
PNG
media_image11.png
428
552
media_image11.png
Greyscale
The difference between WO 753 and the claimed inventions is that WO 753 does not teach the compounds with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, based on the above, WO 753 teaches the structural elements of the instant compounds with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Claims 1 and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 20150314017 based on an application by Zhao (Zhao).
Zhao teaches the following compounds:
PNG
media_image12.png
802
592
media_image12.png
Greyscale
PNG
media_image13.png
366
590
media_image13.png
Greyscale
Specifically:
Y1 and Y2 of Zhou correspond to:
PNG
media_image14.png
108
106
media_image14.png
Greyscale
of the instant compound, e.g.:
See definitions, e.g., haloacetyl or acryloyl:
PNG
media_image15.png
860
624
media_image15.png
Greyscale
R1 and R2 of Zhou correspond with X1 and X1’ of the instant compounds (e.g., alkyl);
L2 and L2’ of the instant compounds are absent;
N-N of the Zhou correspond to T of the instant compounds (i.e., =N-N=);
L1 of the instant compounds are absent;
R3 and R4 of Zhou correspond with R1 of the instant compounds (e.g., alkyl).
Z1 and Z2 of Zhou correspond with Y of the instant compounds:
PNG
media_image16.png
658
572
media_image16.png
Greyscale
The recited conjugates are therefore taught:
PNG
media_image17.png
192
468
media_image17.png
Greyscale
In this way, the difference between Zhao and the claimed inventions is that Zhao does not teach the compounds with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, based on the above, Zhao teaches the structural elements of the instant compounds with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Claims 1 and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015151081 (WO 081).
WO 081 teaches the following conjugates:
PNG
media_image18.png
460
483
media_image18.png
Greyscale
PNG
media_image19.png
715
498
media_image19.png
Greyscale
PNG
media_image20.png
282
477
media_image20.png
Greyscale
PNG
media_image21.png
392
488
media_image21.png
Greyscale
PNG
media_image22.png
571
540
media_image22.png
Greyscale
PNG
media_image23.png
332
531
media_image23.png
Greyscale
PNG
media_image24.png
544
458
media_image24.png
Greyscale
see pages 17+
PNG
media_image25.png
250
515
media_image25.png
Greyscale
PNG
media_image26.png
538
484
media_image26.png
Greyscale
Drugs are given, see pages 46+.
Cell binding agents, and their targets, are disclosed, see pages 24+.
The difference between WO 081 and the claimed inventions is that WO 081 does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, WO 081 teaches the structural elements of the instant compounds with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Claims 1 and 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014009774 (WO 774).
WO 774 teaches the following conjugates:
PNG
media_image27.png
154
522
media_image27.png
Greyscale
See definition at pages 3+.
The instant spacers and branched linkers are taught:
PNG
media_image28.png
588
657
media_image28.png
Greyscale
PNG
media_image29.png
133
632
media_image29.png
Greyscale
The difference between WO 774 and the claimed inventions is that WO 774 does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, WO 774 teaches the structural elements of the instant compounds with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
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 and 3-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-28 and 31-34 of copending Application No. 18/706741.
Although the claims at issue are not identical, they are not patentably distinct from each other. Specifically, the compounds covered in the conflicting claims anticipate those covered by the rejected claims. Alternatively, the difference between compounds covered in the conflicting claims and those covered by the rejected claims is that the conflicting claims may not recite the instant compounds with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims the structural elements of the claimed cell compounds with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 42-44 and 46-52 of copending Application No. 18/706736.
Although the claims at issue are not identical, they are not patentably distinct from each other. Specifically, the compounds covered in the conflicting claims anticipate those covered by the rejected claims. Alternatively, the difference between compounds covered in the conflicting claims and those covered by the rejected claims is that the conflicting claims may not recite the instant compounds with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims the structural elements of the claimed cell compounds with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-36 of copending Application No. 18/706734.
Although the claims at issue are not identical, they are not patentably distinct from each other. Specifically, the compounds covered in the conflicting claims anticipate those covered by the rejected claims. Alternatively, the difference between compounds covered in the conflicting claims and those covered by the rejected claims is that the conflicting claims may not recite the instant compounds with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims the structural elements of the claimed cell compounds with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's acting supervisor, Janet Epps-Smith, can be reached at telephone number (571)272-0757. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646