Ex Parte Krishnan

Patent Trial and Appeal Board

Apr 27, 2016

11994752 (P.T.A.B. Apr. 27, 2016)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/994,752 01/04/2008 Ramu Krishnan KRRA0101PUSA 1133
108961 7590 04/27/2016
Krishnan Ramu
6-G, Century Plaza, 560, Anna Salai
Teynampet
Chennai, Tamilnadu, 600018
INDIA
EXAMINER
BORI, IBRAHIM D
ART UNIT PAPER NUMBER
1629
MAIL DATE DELIVERY MODE
04/27/2016 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte
RAMU KRISHNAN
____________

Appeal 2014-001798
Application 11/994,752
Technology Center 1600
____________

Before FRANCISCO C. PRATS, MELANIE L. McCOLLUM, and
RICHARD J. SMITH, Administrative Patent Judges.

SMITH, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to a process
for enhancing the properties of solubility, bioavailability, or bioabsorbability
of a pharmaceutical or drug. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

Appeal 2014-001798
Application 11/994,752

2

STATEMENT OF THE CASE
Claims on Appeal
Claims 1–20, 22–24, and 26–33 are on appeal. (Claims Appendix,
Appeal Br. 6–13.) Independent claim 201 is illustrative and reads as follows:
20. A process for enhancing the properties of solubility, bioavailability,
bioabsorbability of a pharmaceutical or drug reacted with a modifier
compound(s) to obtain a modified pharmaceutical or drug, the process
comprising preparing the modifier compound(s) including the steps of: ai) to
aiv) or bi) to bii),

wherein the steps ai) to aiv) are:
ai) reacting one mole of beta hydroxytricarballyllic acid with three moles of
2aminoethanol such that two of the 2-aminoethanol links to beta
hydroxytricarballyllic acid through an acid amide bond and the remaining
one mole of 2-aminoethanol links to beta hydroxytricarballyllic acid through
an ester bond leaving amino groups free for further reaction,
aii) treating the product of steps (i) with long chain fatty acid halides for
example (z)-9-octadecenoic acid chloride wherein the hydrogens of free
amino groups present in the product of step(a) is/are replaced with (z)-9-
octadecenoic acid moiety,
aiii) treating the product of step (ii) with one mole of beta
hydroxytricarballyllic acid to obtain a tertiary amine compound,
aiv) further treating the product of step (iii) with long chain fatty acid
substitutes at nitrogen of 2-aminoethanol to obtain an acid amide derivative
as a modifier compound-1,

and wherein the steps bi) to bii) are:
bi) reacting one mole of (z)-9-octadecenoic acid with one mole of sulfurous
oxychloride to produce (z)-9-octadecenonyl chloride; further reacting two
moles of (z)-9-octadecenonyl chloride with one mole of 2-aminoethanol to
obtain one mole of 2-aminoethanol bis (z)-9-octadecenoiate;

1 Claim 20 has been reformatted to reflect additions and deletions in pro se
Appellant’s Claims Appendix. See 37 C.F.R. § 41.37(c) (“a brief filed by an
appellant who is not represented by a registered practitioner need only
substantially comply with” paragraph (c)(1)(v) (Claims Appendix)).
Appeal 2014-001798
Application 11/994,752

3

bii) reacting one mole of beta hydroxytricarballyllic acid with three moles of
sulfurous oxychloride; Further reacting one mole of the product obtained in
this step with two moles of the product obtained in step(bi) to obtain one
mole of acyl chloride of beta hydroxytricarballylate bis 2-aminoethanoldi(z)-
9-octadecenoiate labeled as prepared compound-2.

(Id. at 10–11.)
Examiner’s Rejection
Claims 1–20, 22–24, and 26–33 stand rejected under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description
requirement, and specifically as including new matter. (Final Act. 3.)
FINDINGS OF FACT
FF 1. Claim 20 of Appellant’s Original Application2 reads as follows:
20) A process for enhancing the properties like solubility, bioavailability,
bioabsorbability of known pharmaceutical or drug having at least one
reactable site wherein at least one reactive site is reacted with a pre prepared
compound(s) to obtain a modified form of the said known pharmaceutical or
drug(s) exhibiting the enhanced properties as defined and claimed above.

FF 2. Claim 21 of the Original Application reads as follows:

21) A process of preparing the pre prepared compound as claimed in
claim 20 comprises the steps of;
i) reacting one mole of beta hydroxytricarballyllic acid with three
moles of 2-aminoethanol such that two of the 2-aminoethanol links to
beta hydroxytricarballyllic acid through an acid amide bond and the
remaining one mole of 2-aminoethanol links to beta
hydroxytricarballyllic acid through an ester bond leaving amino
groups free for further reaction.
ii) treating the product of steps (i) with long chain fatty acid halides for
example (z)-9-octadecenoic acid chloride wherein the hydrogens of

2 Filed Jan. 4, 2008, National Stage (35 U.S.C. § 371) of
PCT/IN2006/000222 (WO 2007/004236 A2) (“Original Application”).

Appeal 2014-001798
Application 11/994,752

4

free amino groups present in the product of step(a) is/are replaced
with (z)-9-octadecenoic acid moiety.
iii) treating the product of step (ii) with one mole of beta
hydroxytricarballyllic acid to obtain a tertiary amine compound.
iv) further treating the product of step (iii) with long chain fatty acid
substitutes at nitrogen of 2-aminoethanol to obtain an acid amide
derivative as a pre prepared compound-1.

FF 3. Claim 25 of the Original Application reads as follows:
25) A process of preparing the pre prepared compound as claimed in
claim 20 comprises the steps of;
i) reacting one mole of (z)-9-octadecenoic acid with one mole of
sulfurous oxychloride to produce (z)-9-octadecenonyl chloride;
further reacting two moles of (z)-9-octadecenonyl chloride with one
mole of 2-aminoethanol to obtain one mole of 2-aminoethanol bis (z)-
9-octadecenoiate;
ii) reacting one mole of beta hydroxytricarballyllic acid with three
moles of sulfurous oxychloride; Further reacting one mole of the
product obtained in this step with two moles of the product obtained
in step(i) to obtain one mole of acyl chloride of beta
hydroxytricarballylate bis 2-aminoethanoldi(z)-9-octadecenoiate
labeled as prepared compound-2.

ISSUE
Whether a preponderance of evidence of record supports the
Examiner’s finding that claims 1–20, 22–24, and 26–33 fail to comply with
the written description requirement of 35 U.S.C. § 112, first paragraph, as
including new matter.
ANALYSIS
In rejecting the claims, the Examiner stated as follows:
[A] review of the original Specification fails to provide written
support for the process comprising preparing the modifier
compound(s) including the steps of: ai) to aiv) or bi) to bii,
recited in the amended claim 20. Therefore, it is considered as
Appeal 2014-001798
Application 11/994,752

5

new matter. [Applicant is] required to provide sufficient written
support for the limitation recited in present [claim] 20 in the
specification or claims as filed or remove these limitations from
the claims in response to this Office Action. Claims 1–19, 22–
24 and 26–33 depend from claim 20 and therefore, inherit the
deficiency of claim 20.
(Final Act. 4–5.)
In response, Appellant pointed out the “merging [of original] claims
21 and 25 with other suitable claims.”3 (Appeal Br. 2.) We construe this as
referring to the inclusion in claim 20 of sections i) to iv) of original claim 21
(FF 2) as sections ai) to aiv), and sections i) and ii) of original claim 25 (FF
3) as sections bi) and bii).4
The Examiner bears the initial burden of establishing a prima facie
case of unpatentability and has not done so. See In re Oetiker, 977 F.2d
1443, 1445 (Fed. Cir. 1992). An original claim is part of the disclosure at
the time of filing. In re Anderson, 471 F.2d 1237, 1238–39 (CCPA 1973);
see also MPEP 608.01 (l) (“In establishing a disclosure, applicant may rely
not only on the description and drawing as filed but also on the claims
present on the filing date of the application if their content justifies it.”).
The Examiner’s Answer includes a chronological list of portions of
the prosecution history. (Ans. 4–6.) Included in that list is the statement
that “[t]he recited limitation ‘ai) to aiv)’ (in withdrawn claim 21), was not
part of original Examination, and would have been rejected for lack of

3 Because Appellant is acting pro se, we liberally construe Appellant’s
filings. See Erickson v. Pardus, 551 U.S. 89, 94 (2007) (“A document filed
pro se is ‘to be liberally construed.’”) (quoting Estelle v. Gamble, 429 U.S.
97, 106 (1976)).
4 According to the Examiner, this amendment to claim 20 was filed on May
31, 2012. (Ans. 2.)
Appeal 2014-001798
Application 11/994,752

6

written description.” (Id. at 5.) The Examiner also explains why
Appellant’s argument, that support for claim limitations ai) to aiv) is found
at paragraphs 58–60 of the Specification, is unpersuasive.5 (Id. at 6–8.)
However, nowhere does the Examiner explain why claim 20 is not entitled
to rely on the originally filed claims for written description support.
We find that a comparison of the originally filed claims 20, 21, and 25
(FF 1–3) to present claim 20 establishes that the subject matter of original
claims 21 and 25 was essentially incorporated into claim 20, and that claim
20 thus finds support in the original disclosure. That is, the disclosure of the
Original Application reasonably conveys that Appellant had possession at
that time of the subject matter of claim 20. See Vas-Cath Inc. v. Mahurkar,
935 F.2d 1555, 1563 (Fed. Cir. 1991). Accordingly, the Examiner has failed
to establish that claim 20 is unpatentable for failing to comply with the
written description requirement.
Patent Term
Appellant’s Appeal Brief also includes a request “to grant the
extension of patent term under the proviso of relevant rules.” (Appeal Br.
6.) However, such a request is not within the jurisdiction of the Patent Trial
and Appeal Board.
CONCLUSION
A preponderance of evidence of record fails to support the Examiner’s
finding that claims 1–20, 22–24, and 26–33 fail to comply with the written
description requirement of 35 U.S.C. § 112, first paragraph.

5 It appears from the record that the focus on paragraphs 58–60 arose from
the failure to consider the original claims as part of the disclosure.
Appeal 2014-001798
Application 11/994,752

7

SUMMARY
We reverse the rejection on appeal.

REVERSED