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 .1
Status of Claims
Claims 1-9 and 14-22 are pending.
Election/Restriction
Applicant’s species election (below) without traverse, in the reply filed on June 23, 2026 is acknowledged.
Species of a CD19 inhibitor: tafasitamab (MOR-208)2, a monoclonal antibody
Species of a BTK inhibitor, Acalabrutinib aka CALQUENCETM 3
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Species of Additional therapeutic to be administered:
Anti-CD20 antibody: rituximab.
Chemotherapeutic regimen: (1) fludarabine, cyclophosphamide & rituximab.
iii. PD-1 or PD-L1 inhibitor: pembrolizumab.
Species of cancer: diffuse large B cell lymphoma.
Claims 1-5, 7, 14-16 and 19-22 are under examination (directed to examined species). Claims 6,8-9 and 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 23, 2026.
Regarding the elected species combination of tafasitamab/Calquence, the specification references the elected BTK inhibitor species, Calquence (aka Acalabrutinib) at paragraph 364. Further, the specification references the elected CD19 inhibitor, tafasitamab (MOR-208) at paragraph 452. Note that the examined species has been expanded to include the BTK inhibitor ibrutinib and an anti-CD19 chimeric antigen receptor T cells (aka CART19) and MCL as cancer treated.
Information Disclosure Statement
At this time, an IDS has not been filed.
Claim Rejections - 35 USC § 112
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 1-5, 7, 14-16 and 19-22 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.
Claim 1 recites variations thereof, i.e. the fragments, conjugate, variants or any biosimilar of the CD19 inhibitors and BTK inhibitor prodrugs. Dependent claims 2-5 7, 14-16 and 19-22 are rejected as being dependent upon claim 1. Note that dependent claims 15 and 19 recites these indefinite terms with regard to anti-CD20 antibody and PD-1/PDL-1 inhibitor.
The common usage of the terms fragments, conjugates and variants, does not guide a person having ordinary skill in the art (PHOSITA) to determine the metes and bounds of the claimed CD19 or PD-1/PDL-1 inhibitors and anti CD20 antibodies, as these terms can refer to any portion of such inhibitors, antibodies and variants thereof (i.e., what fragment or conjugate portion, or what endless variant thereof is claimed). Note the specification does not cure this lack of definition as recited in the claim, as there are no examples or definitions to guide a PHOSITA to the particular metes and bounds of these indefinite terms.
Further, the art acknowledged definition of biosimilar fails to define the claimed gamut of CD19 inhibitors and anti CD20 antibodies. Paragraph 321 of the specification, relies upon the art understood definition of biosimilars. “Biosimilars” are biological products of CD19 inhibitors designated by U.S., European and other regulatory agencies. These "biosimilar" medicines are those that are similar to another biological medicine that has already been authorized for use by the country’s or region’s regulatory authority (FDA, EMA, etc.). The legal similarity of these medicines vary from country to country.
However, due to the varying requirements of the various individual countries and regional regulatory authorities, the term biosimilar is indefinite as it is unknown what country, region or regulatory agency definition of biosimilar is being claimed by Applicant.
With regard to the indefinite term “prodrug” of the BTK inhibitor, prodrugs are understood in the art to be for any modified drug compound that is converted by a subject’s metabolism in vivo to release said active drug compound. Use of the term prodrug is indefinite, because without further definition by the specification or limitation of the claims of any potential chemical modifications, a PHOSITA will not know the particular metes and bounds of the claimed BTK inhibitor prodrug. Note the specification does not cure this lack of definition for this term as recited in the claim, as there are no examples or definitions to guide a PHOSITA to the particular metes and bounds of the claimed BTK inhibitor prodrug.
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 1-5, 7, 14-16 and 19-22 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Claimed Invention
The claims are broadly drawn to a method of treating cancer comprising co-administering to a human subject, therapeutically acceptable effective amounts of 1) a CD19 inhibitor or an antigen-binding fragment, conjugate, variant, or biosimilar thereof, and 2) a BTK inhibitor or a prodrug, selected from the group disclosed therein including elected species, tafasitamab, aka MOR-208. See claim 1. Also see dependent claims 7, 15, etc. reciting they are directed to antigen-binding fragment, conjugate, variant, or biosimilar thereof of CD19 inhibitors, the claimed anti-CD20 antibody and PD-1/PDL-1 inhibitors thereof.
Dependent claims 2-5, 7, 14-16 and 19-22 are similarly rejected as their scope is not supported by the specification.
Certain narrower embodiments of the claimed invention are presented in various dependent claims. Some of these claims further limit the claimed inhibitors and antibodies, etc. as detailed therein. While claim 5 specifically recites specific BTK inhibitors to provide adequate written description, it nonetheless claims undescribed aspects with regard to the CD19 inhibitors variations thereof, i.e. the fragments, conjugate, variants or any potential biosimilar, and prodrugs of the claimed BTK inhibitors.
The specification does not teach or disclose the full scope of the rejected compound claims to demonstrate that the inventors had possession of the clamed method.
The Supporting Disclosure
Applicants’ supporting disclosure contains certain descriptions and embodiments of the claimed invention.
In the present case, the important factors leading to a conclusion of inadequate written description is the absence of sufficient working examples of the invention as claimed, and the lack of predictability in the art.
In the present case there is no disclosure to fully support the claimed CD19 inhibitors, BTK inhibitors, PD-1/PDL-1 inhibitors or anti-CD20 antibodies, as claimed, and especially variations thereof, i.e. the fragments, conjugates, variants or any potential biosimilar or prodrugs.
In contrast to the broad scope of CD19 inhibitors, anti-CD20 antibodies, and broad description of ANY best fragments, conjugate, variants or any potential biosimilar, and prodrugs of BTK inhibitors, Applicant was merely in possession of CD19 and BTK inhibitors recited in the specification; see starting at paragraph 441; see also paragraph 452 for disclosure of tafasitamab; BTK inhibitors, paragraphs 470-473; and the Markush group of anti-CD20 antibody of rituximab, obinutuzumab, ofatumumab, veltuzumab, tositumomab, ibritumomab. See specification at paragraph 467.
As defined by paragraph 321 of the specification, “biosimilar” are biological products of CD19 inhibitors designated by U.S., European and other regulatory agencies. These "biosimilar" medicines are those that are similar to another biological medicine that has already been authorized for use by the country’s or region’s regulatory authority (FDA, EMA, etc.). The legal similarity of these medicines vary from country to country.
However, due to the varying requirements of the various individual countries and regional regulatory authorities, it is clear that Applicant claiming of biosimilar products is not within their possession. A biological product, designated to be biosimilar by one country or region, may or may not be a biosimilar in another country or region. For this reason, Applicant cannot be said to be possession of ALL biosimilar CD19 inhibitory products.
Applicant’s disclosure of the CD19, BTK, PD1/PDL-1 inhibitors and anti-CD20 antibodies detailed above is not a sufficient representation of all the claimed compounds, fragments, variants, conjugates, biosimilar, prodrugs, etc. of claim 1 (and rejected dependent claims) as presently pending.
Other than the working examples of the specification as detailed above, Applicant has not reasonably described a scientific or “systematic” approach to synthesize the full scope of claim 1 and claims dependent. See MPEP 2163.02, the standard for determining compliance with the written description.4
Accordingly, Applicant has not adequately described the invention for the breadth that is claimed. Applicant was not in possession of the claimed invention at the time the application was filed, the full scope of compounds of formula I, and that Applicants’ species do not support the claimed genus.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 7 and 20-22 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Ruella et al. "Combination of Ibrutinib and ANTI-CD19 Chimeric Antigen Receptor T-Cells for the Treatment of Relapsing/Refractory Mantle Cell Lymphoma (MCL)", Poster Presentation, 20TH CONGRESS OF THE EUROPEAN HEMATOLOGY ASSOCIATION, JUN 11-14, 2015, VIENNA, AUSTRIA, 13 June 2015 (2015-06-13), pages 1-1, XP55281361. Ruella is cited on the PTO-892 form.
Regarding claims 1 and 3 and the method of treating cancer in a human with the claimed combination, Ruella discloses the combination of the BTK inhibitor ibrutinib and an anti-CD19 chimeric antigen receptor T cells (aka CART19) for the treatment of mantle cell lymphoma, see title and Introduction. Ruella demonstrates that a BTK inhibitor (ibrutinib) can be combined with a CD19 inhibitor leading to an increased anti-tumor effect and enhanced survival, see Conclusions.
Regarding the treatment of a human subject, Ruella references Wang et al. New England Journal of Medicine 2013, where subjects suffering from Mantle Cell Lymphoma were human subjects, see Introduction.
Ruella teaches a co-administration of CART19 and ibrutinib, which teaches the simultaneous administration of claim 3.
Regarding claim 7 and the limitations of a CD19 inhibitor antigen-binding fragment, conjugate or variant, Ruella teaches the use of anti-CD19 chimeric antigen receptor T cells (aka CART19), see title and rest of poster.
Regarding claims 20-22 and the limitations of hyperproliferative disease (cancer) and B-cell/mantle cell lymphoma, Ruella teaches the treatment of MCL, see title and rest of poster.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-5, 7 and 20-22 is/are rejected under 35 U.S.C. 103 as obvious over Ruella et al. "Combination of Ibrutinib and ANTI-CD19 Chimeric Antigen Receptor T-Cells for the Treatment of Relapsing/Refractory Mantle Cell Lymphoma (MCL)", Poster Presentation, 20TH CONGRESS OF THE EUROPEAN HEMATOLOGY ASSOCIATION, JUN 11-14, 2015, VIENNA, AUSTRIA, 13 June 2015 (2015-06-13), pages 1-1, XP55281361 in view of WO 2015/083008 (WO 008) and Kellner et al. Leukemia (2013) 27, 1595–1598; doi:10.1038/leu.2012.373. Ruella, WO 008 and Kellner are cited on the PTO-892 form.
Regarding claims 1 and 3 and the method of treating cancer in a human with the claimed combination, Ruella discloses the combination of the BTK inhibitor ibrutinib and an anti-CD19 chimeric antigen receptor T cells (aka CART19) for the treatment of mantle cell lymphoma, see title and Introduction.
Ruella demonstrates that a BTK inhibitor (ibrutinib) can be combined with a CD19 inhibitor leading to an increased anti-tumor effect and enhanced survival, see Conclusions. Regarding the treatment of a human subject, Ruella references Wang et al. New England Journal of Medicine 2013, where subjects suffering from Mantle Cell Lymphoma were human subjects, see Introduction.
With regard to the elected species of BTK inhibitor, while Ruella does NOT teach the elected species, Acalabrutinib (aka Calquence or ACP 196), WO 008 teaches it as a BTK inhibitor. See page 172, claim 23, first compound.
WO 008 teaches BTK inhibitors as useful for the treatment of cancer in combination with other anti-cancer drugs, see paragraph 10.
With regard to the elected species of CD19 inhibitor, while Ruella or WO 008 do NOT teach the elected CD19 species, tafasitamab (aka MOR 218), Kellner teaches tafasitamab as a CD19 inhibitor for the treatment of cancer, see title and page 1595, column 2.
A person having ordinary skill in the art (PHOSITA) following the teachings of Ruella to treat cancer with a BTK and CD19 antagonism/inhibition, where the elected species of Acalabrutinib/Calquence is taught by WO 008, and elected species tafasitamab is taught by Kellner, would have found it prima facie obvious to practice the claimed method to treat cancer as claimed. See MPEP 2143 (a) where the rationale to support a finding of obviousness are the prior art elements (Acalabrutinib/Calquence is a known BTK inhibitor and tafasitamab is a known CD19 inhibitor, where it is obvious to substitute known equivalents of BTK and CD19 inhibitors for each other) in combination with known methods (combinations of BTK and CD19 inhibitors to treat cancer as per Ruella) to predictably arrive at the claimed invention.
Regarding claims 2-4, Ruella teaches the co-administration CART19 and ibrutinib, see section entitled Combination of ibrutinib and CART19. As there can only be three possibilities to administer a combination of two drugs (before, after or simultaneously), it would be obvious to administer one before or after the other, or administer the two drugs simultaneously.
Regarding claim 5, the elected species of Acalabrutinib aka CALQUENCETM, is taught by WO 008. See page 172, claim 23, first compound.
Regarding claim 7, Ruella teaches the use of anti-CD19 chimeric antigen receptor T cells (aka CART19), see title and rest of poster.
Regarding claims 20-22 and the limitation of a cancer, i.e. B-cell/mantle cell lymphoma, Ruella teaches the treatment of MCL, see title and rest of poster.
Claim(s) 1-5, 7, and 19-22 is/are rejected under 35 U.S.C. 103 as obvious over Ruella et al. "Combination of Ibrutinib and ANTI-CD19 Chimeric Antigen Receptor T-Cells for the Treatment of Relapsing/Refractory Mantle Cell Lymphoma (MCL)", Poster Presentation, 20TH CONGRESS OF THE EUROPEAN HEMATOLOGY ASSOCIATION, JUN 11-14, 2015, VIENNA, AUSTRIA, 13 June 2015 (2015-06-13), pages 1-1, XP55281361 in view of WO 2015/083008 (WO 008) and Kellner et al. Leukemia (2013) 27, 1595–1598; doi:10.1038/leu.2012.373, in further view of US20180237524 A1, priority to Feb 27, 2015. Ruella, WO 008, Kellner and US 524 are cited on the PTO-892 form.
While claims 1-5, 7 and 20-22 are rendered obvious over Ruella, WO ‘008 and Kellner, they do not teach the particular species of pembrolizumab of said claims, and specifically taught in claim 19.
Regarding claim 19 and the limitation of elected species pembrolizumab, US Pub 524 teaches a method of treating a human subject for a cancer, such as diffuse large B-cell lymphoma (DLBCL), with pembrolizumab, see claims 17-18.
Claim(s) 1-4, 7, 14-16, and 20-22 is/are rejected under 35 U.S.C. 103 as obvious over WO 2011/153514. WO 514 is cited on the PTO-892 form.
Regarding claim 1, and the method of treating cancer in a human with the claimed combination, WO 514 discloses a BTK inhibitor (see claim 1 more specifically ibrutinib, see claims 29 and 61-75) to treat a hematological malignancy (B-cell cancer, such as diffuse large B-cell lymphoma (DLBCL), see claims 25, 27, 62, 91, 92, 94, 98 and 102) and see also generally, abstract, paragraphs 309 and 321. WO 514 discloses treatment of cancer in combination with a CD19 inhibitor (blinatumomab), see paragraph 321.
While WO 514 does not exemplify (i.e., specifically provide a working example of said combination of BTK inhibitor with a CD19 inhibitor to treat cancer), one of ordinary skill in the art would have a reasonable expectation of success in practicing this invention as these combinations are taught by WO 514.
A person having ordinary skill in the art (PHOSITA) following the teachings of WO 514 teaching and suggesting combinations of a CD19 inhibitor in combination with a BTK inhibitor would have found it prima facie obvious to practice the claimed method to treat cancer as claimed. See MPEP 2143 (a) where the rationale to support a finding of obviousness are the prior art elements (BTK inhibitors and CD19 inhibitors are known as chemotherapeutic agents) in combination with known methods (combinations of BTK and CD 19 inhibitors to treat cancer as per Ruella) to predictably arrive at the claimed invention
Regarding claims 2-4 and the limitations of administering the CD19 inhibitor, before, after or simultaneously with the BTK inhibitor, WO 514 discloses co-administration or combination therapies are meant to encompass administration of the selected therapeutic agents to a single patient, and are intended to include treatments in which the agents are administered by the same or different route of administration or at the same or different time, see paragraph 148. Note, as there are limited alternatives to administer one drug before, after or simultaneously to the other, it would be obvious for a PHOSITA to do so as per claims 2-4.
Regarding claim 7 and the limitation of the CD inhibitor blinatumomab, WO 514 discloses treatment of cancer in combination with a CD19 inhibitor (blinatumomab), see paragraph 321.
Regarding claims 14-15 and the limitation of administering rituximab, WO 514 teaches further use of rituximab as an additional agent for the treatment of cancer, see paragraphs 310-315 and claims 84-89.
Regarding claim 16, WO 514 teaches a cancer treatment regimen comprising fludarabine, cyclophosphamide and rituximab. See page 4, lines 21-22.
While not necessarily teaching rituximab as an additional agent for the claimed combination, it would be obvious to do so as per MPEP 2144.06, COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE.5
Regarding claims 20-22 and the limitation of cancer, i.e., B-cell including the elected species DLBCL, WO 514 teaches treatment of diffuse large B-cell lymphoma (DLBCL), see paragraphs 174-184; and claims 25, 27, 62, 91-92, 94, 98 and 102.
Claim(s) 1-5, 7, 14-16 and 19-22 is/are rejected under 35 U.S.C. 103 as obvious over WO 2011/153514 in view of US20180237524A1.
While claims 1-5, 7, 14-16 and 20-22 are rendered obvious over WO 514, it does not teach the species of claims 1-5, 7, 14-16 and 20-22, pembrolizumab, which is particularly claimed by claim 19.
Regarding claim 19, US Pub 524 teaches a method of treating a human subject for a cancer, such as diffuse large B-cell lymphoma (DLBCL), with the elected species pembrolizumab, see claims 17-18.
The basis to support the prima facie case of obviousness is the combination of known equivalents (drugs, such as pembrolizumab, known to treat cancer, such as DLBCL, with other known combinations taught by WO 514) as per MPEP 2144.06, see Footnote 3.
Conclusion and Correspondence
In summary, no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM Y LEE/Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 CONTINUING DATA
This application is a CON of 18/052,635 11/04/2022 ABN
18/052,635 is a CON of 17/692,392 03/11/2022 ABN
17/692,392 is a CON of 17/349,828 06/16/2021 ABN
17/349,828 is a CON of 15/760,373 03/15/2018 ABN
15/760,373 is a 371 of PCT/IB2016/055517 09/15/2016
PCT/IB2016/055517 has PRO 62/277,474 01/11/2016
PCT/IB2016/055517 has PRO 62/243,646 10/19/2015
PCT/IB2016/055517 has PRO 62/218,958 09/15/2015
2 CAS Registry Number 1422527-84-1
Immunoglobulin, anti-(human CD19 antigen) (human-Mus musculus monoclonal MOR00208 heavy chain), disulfide with human-Mus musculus monoclonal MOR00208 κ-chain, dimer
MOR 00208, Tafasitamab, XmAb 5574
3 CAS Registry Number 1420477-60-6
Benzamide, 4-[8-amino-3-[(2S)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl]imidazo[1,5-a]pyrazin-1-yl]-N-2-pyridiny
4-[8-Amino-3-[(2S)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl]imidazo[1,5-a]pyrazin-1-yl]-N-2-pyridinylbenzamide
(S)-4-[8-Amino-3-[1-(but-2-ynoyl)pyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl]-N-(pyridin-2-yl)benzamide
ACP 196
Acalabrutinib
Calquence
4 Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68,119 S.Ct. 304,312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"
5 "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing two conventional spray-dried detergents were held to be prima facie obvious.).
Prosecution Insights